Duns Number:080456871
Device Description: Breathing Bag, Disposable, 3 L
Catalog Number
M1036388
Brand Name
Vital Signs™
Version/Model Number
M1036388
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"
-
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
b711a5e3-b249-459e-b84f-9d20adca469a
Public Version Date
November 16, 2021
Public Version Number
1
DI Record Publish Date
November 08, 2021
Package DI Number
50190752108958
Quantity per Package
20
Contains DI Package
10190752108950
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 | 1068 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 780 |
| 3 | A medical device with high risk that requires premarket approval | 65 |
| U | Unclassified | 1 |