Worldwide distribution: USA (nationwide) including states: AZ, CA, CT, FL, GA, IL, KS, KY, MA, MD, MN, MO, NJ, NM, NY, OH, PA, SC,TX, WA, and WY; and countries of: Australia and Canada.
Description du dispositif
Corometrics Qwik Connect Plus Spiral Electrode- Model #7000AA0 || A fetal scalp circular (spiral) electrode and applicator is a device used to obtain a fetal electrocardiogram during labor and delivery.
Class 1 Exempt Device No Medical Device Listing Number exp date - 13 months from the date received by the distributor. Povidone Iodine Pads: The Povidone Iodine Pad is packaged in the Busse IV Start Kit that is included in the Intra Venous Module, which is contained in the Broselow products referenced below. Affected Armstrong product numbers: Kits: AE-4700, AE 4701, AE-4712, and PBL-PC-9A Modules: 7700RIV, 7700PIV, 7700YIV, 7700WIV, 7700BIV, 7700OIV, 7700GIV, 7730RED, 7730PUR, 7730YEL, 7730WHI, 7730BLU, 7730ORG, and 7730GRN Affected Vital Signs product numbers: Kits: 7730ALS, 7730IALS, 7730FLY, 7730MOD Modules: 7700RIV2, 7700PIV2, 7700YIV2, 7700WIV2, 7700BIV2, 7700OIV2, 7700GIV2, 7730RED5, 7730PUR5, 7730YEL5, 7730WHI5, 7730BLU5, 7730ORG5, and 7730GRN5 Sub-Assembly: 7700RIV, 7700PIV, 7700YIV, 7700WIV, 7700BIV, 7700OIV, and 7700GIV Lot codes of the Broselow Kits and Intra Venous Modules that contain affected Povidone Iodine Pads: 2008: 228F-366F 2009: 010K-258K and 010L-258L
Broselow/Hinkle Pediatric Emergency System || Vital Signs Inc. || 20 Campus Road || Totowa, NJ 07512 USA || The system supplies you with all the information and equipment needed for a young patients' emergency resuscitation requirements, all contained in a color coded, easy-to-use kit
Worldwide distribution: US (nationwide) and countries of: Australia, Belgium, Canada, Czech Republic, Finland, France, Germany, Italy, Lebanon, Netherlands, Norway, Poland, Saudi Arabi, Singapore, South Africa, Spain, Sweden and United Kingdom.
Description du dispositif
Disposable Temperature Probes, (sterile), Sensor diameter: 3mm/0.12 in; 25 units per box. Vital Signs Inc. a GE Healthcare Company, 20 Campus Road, Totowa, NJ 07512 USA, www.gehealthcare.com/vitalsigns. || Continuous temperature monitoring.
a) 510(k): K060537 b) Medical device listing number: D071942 All enFlow Warmer Straps in the field present a potential for tissue injury. Sold separately as Product #: 980304 and 980304EU Included as an accessory in following enFlow products: Military Domestic 91000153 980100 91000154 980100EU 91000156 980105VS 91000103
enFlow IV Fluid Warmer (510k name: EFLOW IV FLUID WARMER, MODEL || 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, || MODEL 120). || The Enginivity enFlow TM IV Fluid Warmer is intended for warming blood, blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia.
Worldwide Distribution - USA (nationwide) and the country of Vietnam
Description du dispositif
enFlow IV Fluid Warmer Part number 980105VS; || (510K name: enFlow IV Fluid Warmer Model 100, EFlow Disposable Cartridge, Model 200 and EFlow AC Power Supply Model 120) || Intended for warming blood, blood products, and intravenous solutions, prior to administration. Intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia.