Duns Number:025460908
Device Description: RESUS BAG, INFNT, BAG RES, PEEP, MAN
Catalog Number
CPRM3312PM3
Brand Name
Medline
Version/Model Number
CPRM3312PM3
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BTM
Product Code Name
Ventilator, emergency, manual (resuscitator)
Public Device Record Key
ce2ceb74-468b-4da1-8435-09d384b3ec25
Public Version Date
July 22, 2021
Public Version Number
1
DI Record Publish Date
July 14, 2021
Package DI Number
40193489019446
Quantity per Package
12
Contains DI Package
10193489003758
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |