510(k) K873286 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
DISPOSABLE, MANUAL PULMONARY RESUSCITATOR
| Applicant | Hospitak, Inc., Lindenhurst NY, US |
| Decision | Substantially Equivalent, Oct 26, 1987 |
| Received | Aug 17, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K873286
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 4, 2009 | Unomedical Infant Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID # 5801, 12-8713, 732-E, and 2206.
Packaged under the name of Dynarex, Evergreen, Mada and Hospita Terminated |
BTM | None listed |
| Nov 4, 2009 | Unomedical Pediatric Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID #s: 5804; 12-8709, 727-E; 727MM, 2203.
Packaged under the name of Dynarex, Evergreen, Mada and H Terminated |
BTM | None listed |
| Nov 4, 2009 | Unomedical Adult Manual Pulmonary Resuscitator with reservoir tube, face mask & Gas Sampling elbow. Product ID # 5807; 12-8703, 723-E (Foreign Distribution only), 723MM.
Packaged under the name of Dynarex and Terminated |
BTM | None listed |
| Nov 4, 2009 | Unomedical Adult Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID #s 5808, 12-8704; 724-E; 724MM, 32612.
Packaged under the name of Dynarex, Evergreen, Hospitak and Terminated |
BTM | None listed |
| Nov 4, 2009 | Unomedical Adult Manual Pulmonary Resuscitator with reservoir tube, face mask & standard elbow. Product ID #: 12-8702; 778500; 721-E, 778500; 2200; 2201, 86-721E, 40-116722 (foreign distributiuon only), 721MM.
Terminated |
BTM | None listed |
| Nov 4, 2009 | Unomedical Manual Pulmonary Resuscitator, Adult w/ Large Adult Mask & Reservoir Bag. Product # 12-8705.
Packaged under the name of Evergreen. Terminated |
BTM | None listed |
| Nov 4, 2009 | Unomedical Pediatric Manual Pulmonary Resuscitator w/Luer-lock Sampling Elbow & Reservoir bag (No mask). Product ID# 12-8707.
Packaged under the name of Evergreen. Terminated |
BTM | None listed |
| Nov 4, 2009 | Unomedical Pediatric Manual Pulmonary Resuscitator. Product ID # 12-8708.
Packaged under the name of Evergreen. Terminated |
BTM | None listed |
| Nov 4, 2009 | Unomedical Pediatric Manual Pulmonary Resuscitator with reservoir tube, face mask & standard elbow. Product ID # 12-8710, 726-E; 86-722E, 726MM.
Packaged under the name of Evergreen, Hospitak, and McKesson. Terminated |
BTM | None listed |
| Nov 4, 2009 | Unomedical Infant Manual Pulmonary Resuscitator with reservoir tube, face mask & Gas sampling elbow. Product ID # 12-8714; 731-E, 731MM; 86-731E.
Packaged under the name of Evergreen, Hospitak and McKesson. Terminated |
BTM | None listed |
| Nov 4, 2009 | Unomedical Adult Manual Pulmonary Resuscitator with reservoir bag, face mask & standard elbow. Product ID # 722-E, 86-722-E; 722MM.
Packaged under the name of Hospitak and McKesson Terminated |
BTM | None listed |
| Nov 4, 2009 | Unomedical Hospitak Pediatric Manual Pulmonary Resuscitator with reservoir bag, face mask & swivel Gas Sampling Elbow. Product ID #: 728-E. Terminated |
BTM | None listed |
| Nov 4, 2009 | Unomedical Hospitak Pediatric Manual Pulmonary Resuscitator with reservoir tube, face mask and Pop-Off 40 Cm H2O Elbow. Product ID #s: 729-E; 40-116730; Foreign distribution only; 729MM. Terminated |
BTM | None listed |
| Nov 4, 2009 | Unomedical Hospitak Pediatric Manual Pulmonary Resuscitator with reservoir bag, face mask and Pop-Off 40 cm H2O Elbow. Product ID # 730-E;
Hospitak Infant Manual Pulmonary Resuscitator with reservoir bag, face Terminated |
BTM | None listed |
| Nov 4, 2009 | Unomedical Manual Pulmonary Resuscitator with reservoir tube and Peep Valve. Product ID #s 742-E; 86-742E.
Packaged under the name of Hospitak, McKesson. Terminated |
BTM | None listed |
| Nov 4, 2009 | Unomedical Hospitak Infant Manual Pulmonary Resuscitator with reservoir bag, face mask and Pop-Off 40 Cm H2O Elbow. Product ID # 735-E; Distributed in France only: product code: 40-116735. Terminated |
BTM | None listed |
| Nov 4, 2009 | Unomedical Hospitak Adult Manual Pulmonary Resuscitator with reservoir bag, face mask & swivel gas sampling elbow. Foreign distribution only.
Product code: 725-E, Terminated |
BTM | None listed |
| Nov 4, 2009 | Unomedical Drager Medical Infant Manual Pulmonary Resuscitator with reservoir bag, face mask and swivel gas sampling elbow, Peep Valve. Product code: 40-116733, Distribution to France only. Terminated |
BTM | None listed |
| Nov 4, 2009 | Unomedical Hospitak Infant Manual Pulmonary Resuscitator with reservoir bag, face mask & swivel Gas sampling elbow. foreign Distribution only:
Product number 733-E. Terminated |
BTM | None listed |
| Nov 4, 2009 | Unomedical Hospitak Infant Manual Pulmonary Resuscitator with reservoir tube, face mask and Pop-Off 40 cm H2O Elbow. Foreign distribution only:
Product codes: 734-E, 734MM. Terminated |
BTM | None listed |
| Nov 4, 2009 | Unomedical Unomedical Adult Manual Pulmonary Resuscitator, Adult Medium Mask w/ Reservoir Bag. Product ID # 779725 Terminated |
BTM | None listed |
| Nov 4, 2009 | Unomedical Unomedical Pediatric Manual Pulmonary Resuscitator, Child Mask & Reservoir Hose, Product ID # 779728 Terminated |
BTM | None listed |
| Nov 4, 2009 | Unomedical Unomedical Infant Manual Pulmonary Resuscitator, Infant Mask & Reservoir Hose. Product ID # 779733 Terminated |
BTM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.