Duns Number:008124539
Device Description: Post-Mortem Bag Kit (Body Bag) Bariatric, 72"x96", Contents: Body Bag, (3) toe tags, shrou Post-Mortem Bag Kit (Body Bag) Bariatric, 72"x96", Contents: Body Bag, (3) toe tags, shroud sheet, (4) precaution labels, white vinyl disposable gloves
Catalog Number
-
Brand Name
Post-Mortem Bag Kit
Version/Model Number
4775
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
KME
Product Code Name
Bedding, Disposable, Medical
Public Device Record Key
cdd8a0e0-45c3-44ca-b1e5-8a5679e2db4a
Public Version Date
September 09, 2021
Public Version Number
1
DI Record Publish Date
September 01, 2021
Package DI Number
00616784477534
Quantity per Package
5
Contains DI Package
00616784477510
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 | 694 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 226 |
| 3 | A medical device with high risk that requires premarket approval | 2 |