Duns Number:025460908
Device Description: BREATHING BAG-3L, BULK-LF
Catalog Number
3523BB
Brand Name
Medline Industries, Inc.
Version/Model Number
3523BB
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
BTC
Product Code Name
BAG, RESERVOIR
Public Device Record Key
2764da8d-be6c-4643-8e50-a5592319406b
Public Version Date
August 12, 2022
Public Version Number
1
DI Record Publish Date
August 04, 2022
Package DI Number
40884389447100
Quantity per Package
250
Contains DI Package
10884389447109
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 |