AccessGUDID - DEVICE: Future Generation Medical (10850046230094)

GUDID

Device Identifier (DI) Information

Brand Name: Future Generation Medical
Version or Model: FG-IHW-5003
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Global International L. L. C.

Primary DI Number: 10850046230094
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 079251688 *Terms of Use

Device Description: Infant Heel Warmers - With Disc

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?
40555	Hot/cold therapy pack, single-use	A non-sterile device intended to be applied with or without pressure to the body surface (i.e., non-invasively) to provide heat and/or cold therapy for the skin and/or underlying tissues in the treatment of musculoskeletal pain and discomfort (e.g., from sports injuries or rheumatism). It consists of a compact envelope filled with a thermally-retentive material (e.g., silicate-based gel, peat) that can be heated and/or cooled. It may be shaped/sized to fit a specific anatomy or include a strap; it is not intended to support the neck. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MPO	Infant Heel Warmer (Chemical Heat Pack)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K053254	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Dry Heat Sterilization

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: 22461f4f-9d2f-489b-8603-53ded033f557
Public Version Date: November 21, 2022
Public Version Number: 1
DI Record Publish Date: November 13, 2022