Duns Number:086911794
Device Description: An emergency medical blanket intended for to be used by one patient for a period of time a An emergency medical blanket intended for to be used by one patient for a period of time and then discarded.
Catalog Number
81001
Brand Name
Medi-First Emergency Survival Blanket
Version/Model Number
81001
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
KME
Product Code Name
Bedding, Disposable, Medical
Public Device Record Key
7a3a7027-f4a2-4d65-8cb1-af608c206bf4
Public Version Date
July 22, 2019
Public Version Number
1
DI Record Publish Date
July 12, 2019
Package DI Number
50347682810011
Quantity per Package
200
Contains DI Package
00347682810016
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 | 110 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| U | Unclassified | 1 |