Duns Number:025460908
Device Description: PACK,COLD,INSTANT,HEAVY-WEIGHT,6X10
Catalog Number
MDS138000
Brand Name
Medline
Version/Model Number
MDS138000
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IMD
Product Code Name
PACK, HOT OR COLD, DISPOSABLE
Public Device Record Key
584ce2cc-eb8b-4dec-bea6-250f400d721f
Public Version Date
May 24, 2021
Public Version Number
1
DI Record Publish Date
May 14, 2021
Package DI Number
40080196778639
Quantity per Package
4
Contains DI Package
10080196158522
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
RETAIL OUTER PACK
| 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 |