AccessGUDID - DEVICE: MEDICOM SAFEWEAR (10686864046841)

GUDID

Device Identifier (DI) Information

Brand Name: MEDICOM SAFEWEAR
Version or Model: 8105-A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8105-A
Company Name: AMD Medicom Inc

Primary DI Number: 10686864046841
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 12
Labeler D-U-N-S® Number*: 256880576 *Terms of Use

Device Description: MEDICOM SAFEWEAR HIPSTER JACKET Small

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
32170	Professional examination gown, single-use	A garment made of natural and/or synthetic materials intended to be worn by healthcare providers, sometimes over scrub suits, while examining patients. It can be fluid resistant or impervious to fluid. An examination gown is used during patient examination procedures to protect both the patient and staff from the transfer of contaminants such as microorganisms or body fluids. This is a single-use garment.	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
Special Storage Condition, Specify: Cool dry place

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Small

Device Record Status

Public Device Record Key: 8c428b69-c021-4515-86ad-dc1f04cf11e1
Public Version Date: February 18, 2019
Public Version Number: 1
DI Record Publish Date: January 17, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20686864046848	5	10686864046841		In Commercial Distribution	Outer Case

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: 00686864046844 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: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(514)636-6262
Email: amdudi@medicom.ca

Phone: +1(514)636-6262 ext: 2309
Email: dabecassis@amdritmed.com

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