Duns Number:025460908
Device Description: GOWN,ISO,KNITCUFF,PREMIUM BLUE, LV3,REG
Catalog Number
NONLV325
Brand Name
MEDLINE INDUSTRIES, INC.
Version/Model Number
NONLV325
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
f77fff74-fc09-4c10-ae58-ce11b954daba
Public Version Date
April 29, 2022
Public Version Number
2
DI Record Publish Date
December 11, 2020
Package DI Number
40080196765486
Quantity per Package
50
Contains DI Package
10080196765485
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CARTON
| 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 |