AccessGUDID - DEVICE: Coflex NL (10724004402529)

GUDID

Device Identifier (DI) Information

Brand Name: Coflex NL
Version or Model: CPK, 2"X5Yds
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5200CP-036
Company Name: Andover Healthcare, Inc.

Primary DI Number: 10724004402529
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 088528245 *Terms of Use

Device Description: CoFlex NL, Cohesive Flexible Elastic, Latex Free Bandage Compression Self Adherent Wrap, CPK, 2"X5Yds

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?
10284	Pressure bandage, non-latex, single-use	A strip or roll of fabric or plastic material (non-natural rubber latex) intended to be applied to and compress a local area of the body for one or more preventative/therapeutic applications (e.g., prevent oedema, support injuries associated with minor trauma, treat disorders of venous return). It may be described as a sports tape intended for support while allowing movement, or described as a compression bandage; it is not intended to be used in association with open wounds. It is intended for use in the home or healthcare facility. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FQM	Bandage, Elastic

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
Storage Environment Temperature: less than 77 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6a64dcc9-56c0-47b1-864b-a743c3f08993
Public Version Date: April 13, 2022
Public Version Number: 1
DI Record Publish Date: April 05, 2022