AccessGUDID - DEVICE: AMG (00850017650299)

GUDID

Device Identifier (DI) Information

Brand Name: AMG
Version or Model: JSW-CA45SMS04
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ARROW MEDSOURCE GROUP LIMITED

Primary DI Number: 00850017650299
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 686378503 *Terms of Use

Device Description: COVERALL ANTI-STATIC, WHITE, 45g SMS, XL

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
41112	Assistive coverall	A lightweight wrap (e.g., made of vinyl, nylon, or other plastic) specially designed/adapted to be used by a person with a disability to cover and protect them against precipitation (rain, snow, sleet), cold and wind, especially when using a wheelchair, pram, or sledge. The device is typically hooded and has openings to allow access to the operating and steering controls of the occupied transportation device if required.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OEA	Non-Surgical Isolation Gown

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0305f9d5-a1f2-4c35-80b0-03b1f68d5664
Public Version Date: June 30, 2020
Public Version Number: 1
DI Record Publish Date: June 22, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10850017650296	50	00850017650299		In Commercial Distribution	Case

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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