Duns Number:025460908
Device Description: RESUSTATOR,MAN,INF,BAG,FILTER,PEEP,MANO
Catalog Number
CPRM3312FPM
Brand Name
Medline
Version/Model Number
CPRM3312FPM
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
8bf0fb52-daae-4d03-9832-be9e8bde0e96
Public Version Date
November 11, 2021
Public Version Number
1
DI Record Publish Date
November 03, 2021
Package DI Number
20888277654829
Quantity per Package
12
Contains DI Package
10888277654822
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 |