AccessGUDID - DEVICE: Compress Bandage 24"x72" (00840117334618)

GUDID

Device Identifier (DI) Information

Brand Name: Compress Bandage 24"x72"
Version or Model: 3202UB-1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Dynarex Corporation

Primary DI Number: 00840117334618
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 008124539 *Terms of Use

Device Description: No description.

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?
58805	Absorbent wound compression pad	A rolled strip of fabric material (e.g., non-woven polyester) intended to be applied around a wound (e.g., venous stasis ulcer of the leg) as a supplemental padded layer for a pressure bandage, primarily to help evenly distribute pressure and absorb exudates during the compression treatment of the wound. It is intended for use in the home or a clinical setting. 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: Yes
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: 5367fb53-fbcf-4ad2-b819-f841b40525aa
Public Version Date: October 09, 2024
Public Version Number: 2
DI Record Publish Date: March 25, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
00840117332492	1	00840117334618		In Commercial Distribution	Box
00840117332485	50	00840117332492		In Commercial Distribution	Mc

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: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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