Duns Number:001403807
Device Description: SAFETY VEST
Catalog Number
-
Brand Name
E.M. Adams Co, Inc.
Version/Model Number
EP90612S-1
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
-
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
K971948,K971948
Product Code
FMQ
Product Code Name
Restraint, Protective
Public Device Record Key
536a9d51-bf0d-4c22-874b-ad6743c1dcda
Public Version Date
May 23, 2022
Public Version Number
1
DI Record Publish Date
May 13, 2022
Package DI Number
50840200324477
Quantity per Package
24
Contains DI Package
10840200324486
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 | 1447 |
2 | A medical device with a moderate to high risk that requires special controls. | 11 |