AccessGUDID - DEVICE: Argyle (30884527004632)

GUDID

Device Identifier (DI) Information

Brand Name: Argyle
Version or Model: MH00002T
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: MH00002T
Company Name: Cardinal Health, Inc.

Primary DI Number: 30884527004632
Issuing Agency: GS1
Commercial Distribution End Date: December 27, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 080935429 *Terms of Use

Device Description: Infant Heel Warmer,Attachment Tab

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?
36816	Instrument warmer, electric	An electrically-powered heating device intended to warm patient-contact instruments (e.g., rigid endoscopes or trocars) before they are introduced into body orifices or other parts of the body. It typically consists of a tabletop device that has recesses or wells for placement of the instrument insertion portion, a heating element, a thermostat and operating controls.	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 [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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: Fragile;

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 916f2436-459c-443a-936c-f80b65a88190
Public Version Date: August 01, 2023
Public Version Number: 4
DI Record Publish Date: June 30, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20884527004635	100	30884527004632	2022-12-27	Not in Commercial Distribution	CASE
10884527004638	25	30884527004632	2022-12-27	Not in Commercial Distribution	PACK_OR_INNER_PACK