Duns Number:176528040
Device Description: A device intended to be applied with pressure to the body surface to provide cold therapy A device intended to be applied with pressure to the body surface to provide cold therapy - Medium
Catalog Number
3302
Brand Name
Green GuardInstant Cold Pack
Version/Model Number
3302
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)
-
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
2876a2e3-c745-4c11-aa86-1fb55ea352dd
Public Version Date
July 04, 2019
Public Version Number
1
DI Record Publish Date
June 26, 2019
Package DI Number
50347682033021
Quantity per Package
48
Contains DI Package
00347682033026
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
master case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 36 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| U | Unclassified | 1 |