AccessGUDID - DEVICE: American Red Cross (B268Y7054Y70570)

GUDID

Device Identifier (DI) Information

Brand Name: American Red Cross
Version or Model: Y7054, Y7057
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Y7057
Company Name: TOMY INTERNATIONAL, INC.

Primary DI Number: B268Y7054Y70570
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 065183758 *Terms of Use

Device Description: Y7057 American Red Cross Healthcare & Grooming Kit (with Thermometer)

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:	No
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?
10243	Infant care kit	A portable collection of devices and supplies designed to assist in the care of an infant/baby that typically includes two or more of the following: a thermometer, medical measuring spoon/dropper, nasal aspirator, irrigation saline solution, a teether, and nail clippers. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FLL	Thermometer, Electronic, Clinical

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b7842ee2-253b-40aa-8fa3-8e8f8f1006fa
Public Version Date: November 09, 2022
Public Version Number: 4
DI Record Publish Date: December 29, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
B268Y7054Y70579	12	B268Y7054Y70573	In Commercial Distribution	Master
B268Y7054Y70573	3	B268Y7054Y70571	In Commercial Distribution	Inner
B268Y7054Y70571	1	B268Y7054Y70570	In Commercial Distribution	Retail