Duns Number:025460908
Device Description: RESUSCITATOR,MANUAL,ADLT,MASK,TUBE RES
Catalog Number
CPRM1126
Brand Name
Medline Industries, Inc.
Version/Model Number
CPRM1126
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
abd40bfa-3ef9-4f58-8af4-431d91118268
Public Version Date
October 21, 2019
Public Version Number
4
DI Record Publish Date
October 15, 2015
Package DI Number
40884389125916
Quantity per Package
6
Contains DI Package
10884389125915
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| 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 |