Duns Number:017246562
Device Description: STERILE BABY BLANKET
Catalog Number
DYNDA1838
Brand Name
MEDLINE
Version/Model Number
DYNDA1838
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)
Yes
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
3b67397d-333e-45f4-88d9-410c5de07d5e
Public Version Date
June 17, 2022
Public Version Number
3
DI Record Publish Date
April 03, 2020
Package DI Number
40889942702771
Quantity per Package
50
Contains DI Package
10889942702770
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 | 6043 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4077 |
| U | Unclassified | 1 |