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Crédits
Manufacturers
Apogee Medical
Adresse du fabricant
Apogee Medical, 90 Hearther Ct, Youngsville NC 27596
Source
USFDA
7 Events
Rappel de Device Recall Irrigation Kit
Rappel de Device Recall Irrigation Kit
Rappel de Device Recall Irrigation Kit
Rappel de Device Recall Irrigation Kit
Rappel de Device Recall Irrigation Kit
Rappel de Device Recall Irrigation Kit
Rappel de Device Recall Catheter Insertion Kit
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7 dispositifs dans la base de données
Device Recall Irrigation Kit
Modèle / numéro de série
Catalog number: 6115, Lot numbers: 11267, 11419, 12622.
Classification du dispositif
General Hospital and Personal Use Devices
Classe de dispositif
1
Dispositif implanté ?
No
Distribution
Nationwide Distribution: USA including states of: AL, AZ, CA, FL, GA, IL, IN, KS, LA, MA, MO, NC, NJ, NY, OH, OK, PA, TN, TX, VA and WA.
Description du dispositif
Irrigation Kit, Small, Vinyl, REF: 6116, Apogee Medical, LLC, 90 Weathers Street, Youngsville, NC 27596. || Intended use: Kit components to be used during Intermittent Urinary Catheterizations.
Device Recall Irrigation Kit
Modèle / numéro de série
Catalog number: 6115, Lot numbers: 11266, 11418, 12116, 12275, 12769, 13158, 13317, 13550, 13738, 14948, 15783, 15991, 16884, 17383, 17958, 18911, 19761.
Classification du dispositif
General Hospital and Personal Use Devices
Classe de dispositif
1
Dispositif implanté ?
No
Distribution
Nationwide Distribution: USA including states of: AL, AZ, CA, FL, GA, IL, IN, KS, LA, MA, MO, NC, NJ, NY, OH, OK, PA, TN, TX, VA and WA.
Description du dispositif
Irrigation Kit, Medium, Vinyl, REF: 6115, Apogee Medical, LLC, 90 Weathers Street, Youngsville, NC 27596. || Intended use: Kit components to be used during Intermittent Urinary Catheterizations.
Device Recall Irrigation Kit
Modèle / numéro de série
Catalog number: 6114, Lot numbers: 11121, 11265, 11417, 11697, 11883, 12274, 12621, 12768, 13006, 13315, 13318, 13549, 13739, 14095, 14947, 15782, 15990, 17017, 17382, 17730, 18476, 18910, 19555, 19759, 20021.
Classification du dispositif
General Hospital and Personal Use Devices
Classe de dispositif
1
Dispositif implanté ?
No
Distribution
Nationwide Distribution: USA including states of: AL, AZ, CA, FL, GA, IL, IN, KS, LA, MA, MO, NC, NJ, NY, OH, OK, PA, TN, TX, VA and WA.
Description du dispositif
Irrigation Kit, Large, Vinyl, REF: 6114, Apogee Medical, LLC, 90 Weathers Street, Bournesville, NC 27596. || Intended use: Kit components to be used during Intermittent Urinary Catheterizations.
Device Recall Irrigation Kit
Modèle / numéro de série
Catalog number: 6113, Lot numbers: 11264, 11416, 12273, 13273, 14094.
Classification du dispositif
General Hospital and Personal Use Devices
Classe de dispositif
1
Dispositif implanté ?
No
Distribution
Nationwide Distribution: USA including states of: AL, AZ, CA, FL, GA, IL, IN, KS, LA, MA, MO, NC, NJ, NY, OH, OK, PA, TN, TX, VA and WA.
Description du dispositif
Irrigation Kit, Small, Latex, REF: 6113, Apogee Medical, LLC, 90 Weathers Street, Youngsville, NC 27596. || Intended use: Kit components to be used during Intermittent Urinary Catheterizations.
Device Recall Irrigation Kit
Modèle / numéro de série
Catalog number: 6112, Lot numbers: 11120, 11263, 11415, 11696, 11881, 12115, 12272, 12635, 12955, 13199, 13547, 13737, 14092, 14944, 14949, 15988, 16183, 16425, 16883, 17380, 17575, 17957, 18477, 18909, 19556, 19760.
Classification du dispositif
General Hospital and Personal Use Devices
Classe de dispositif
1
Dispositif implanté ?
No
Distribution
Nationwide Distribution: USA including states of: AL, AZ, CA, FL, GA, IL, IN, KS, LA, MA, MO, NC, NJ, NY, OH, OK, PA, TN, TX, VA and WA.
Description du dispositif
Irrigation Kit, Medium, Latex, REF: 6112, Apogee Medical, LLC, 90 Weathers Street, Youngsville, NC 27596. || Intended use: Kit components to be used during Intermittent Urinary Catheterizations.
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Apogee Medical, Inc
Adresse du fabricant
Apogee Medical, Inc, 90 Weathers St., Youngsville NC 27596-7801
Source
USFDA
Language
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