Duns Number:008124539
Device Description: Post-Mortem Bag Kit (Body Bag) Adult 36"x90", Contents include: Body Bag, (3) Toe-Tags, Sh Post-Mortem Bag Kit (Body Bag) Adult 36"x90", Contents include: 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
4772
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
0aa61f2c-b08c-413e-8045-853a7d63aca5
Public Version Date
September 09, 2021
Public Version Number
1
DI Record Publish Date
September 01, 2021
Package DI Number
00616784477237
Quantity per Package
10
Contains DI Package
00616784477213
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
10
| 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 |