AccessGUDID - DEVICE: First Aid Only (00092265214001)

GUDID

Device Identifier (DI) Information

Brand Name: First Aid Only
Version or Model: 21-4000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 21-4000
Company Name: Acme United Corporation

Primary DI Number: 00092265214001
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 001180207 *Terms of Use

Device Description: 6" X 9" Instant Cold Pack, Large

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):	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?
60790	Endothermic cold therapy pack	A device intended to be applied with pressure to the body surface to provide cold therapy to help reduce fever, pain, and inflammation associated with joint/muscle/tissue injury and/or minor burns. It typically consists of a compact envelope made of plastic and filled with chemicals that generate an endothermic chemical reaction when activated to reduce the temperature of the pack. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IMD	Pack, Hot Or Cold, Disposable

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: 746e2c6d-1d63-414a-90ea-0bfeb6dcb024
Public Version Date: January 14, 2022
Public Version Number: 1
DI Record Publish Date: January 06, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

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

[?]

Phone: 800-835-2263
Email: xxx@xx.xx

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