Duns Number:256880576
Device Description: AMD-RITMED SMS ISOLATION GOWN Level 1 Large
Catalog Number
A69911-T
Brand Name
AMD-RITMED
Version/Model Number
A69911-T
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OEA
Product Code Name
Non-surgical isolation gown
Public Device Record Key
0d9807fe-80f6-4cc1-b1ca-7e47fdfda9e6
Public Version Date
February 18, 2019
Public Version Number
1
DI Record Publish Date
January 17, 2019
Package DI Number
20686864055338
Quantity per Package
10
Contains DI Package
10686864055331
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Outer Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 84 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |
| U | Unclassified | 2 |