FDA UDI In Commercial Distribution 🇺🇸 United States

A Plus

DI: 00683534060537 · Model: 1 · A PLUS INTERNATIONAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

Basic Information

Brand Name
A Plus
Primary DI
00683534060537
Version / Model
1
Catalog Number
68-901B
Company Name
A PLUS INTERNATIONAL INC.
Labeler DUNS
191705904
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-12-21
Public Version
2
Public Version Date
2023-08-03
Public Version Status
Update
Public Device Record Key
38969c5c-7f72-40f2-8419-3137ad98e137

Device Description

P/E FILM GOWN BLUE;1/BG, 100/CS

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
Yes
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
LYU Accessory, Surgical Apparel

GMDN Terms

Code Name
35492 Isolation gown, single-use

Identifiers

Type ID
Package 70683534060536
Primary 00683534060537
Package 80683534060533