Duns Number:025460908
Device Description: GOWN,ISO,MDWGHT,SIDETIE,LV3,YEL,REG
Catalog Number
NONLV340
Brand Name
MEDLINE INDUSTRIES
Version/Model Number
NONLV340
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
FYC
Product Code Name
Gown, isolation, surgical
Public Device Record Key
6192b84d-2e5c-4582-9a9c-c12f4ea3140a
Public Version Date
December 14, 2020
Public Version Number
1
DI Record Publish Date
December 04, 2020
Package DI Number
30888277699568
Quantity per Package
100
Contains DI Package
20888277699561
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 | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |