Duns Number:080361159
Device Description: 12 X 15 MEDFUSION, 2MIL, 3-WALL, BAR CODE(B3000001), ZIP LOCK, W/ABSORBENT PAD, 100/PK, 50 12 X 15 MEDFUSION, 2MIL, 3-WALL, BAR CODE(B3000001), ZIP LOCK, W/ABSORBENT PAD, 100/PK, 500/CS
Catalog Number
-
Brand Name
THERAPACK, LLC
Version/Model Number
15567G
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NNK
Product Code Name
Container, Specimen Mailer And Storage, Non-Sterile
Public Device Record Key
20411b28-4d55-405b-a857-0d6dc9887067
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
March 20, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1046 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |
| U | Unclassified | 2 |