Duns Number:021899778
Catalog Number
H1982
Brand Name
H1982 HomeCare Standard Crib
Version/Model Number
H1982
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FMS
Product Code Name
Bed, Pediatric Open Hospital
Public Device Record Key
18a5cc31-f216-4d16-9751-af42dc576015
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
February 20, 2017
Package DI Number
10852231007733
Quantity per Package
1
Contains DI Package
00852231007736
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Pallet
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 63 |