AccessGUDID - DEVICE: Smart Care (00850010842325)

GUDID

Device Identifier (DI) Information

Brand Name: Smart Care
Version or Model: 84232-24
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ASHTEL STUDIOS, INC

Primary DI Number: 00850010842325
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 4
Labeler D-U-N-S® Number*: 148689180 *Terms of Use

Device Description: Fisher-Price Healthcare Kit 6pcs: 1 x medicine dropper, 1 x medicine spoon, 1 x digital thermometer, 1 x nasal aspirator, 1 x emergency card, 1 nail clipper

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":	Yes
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
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
KYX	Dispenser, Liquid Medication
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered
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: 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: cbbbfa20-f9cb-4bd5-97c1-def148d8fb90
Public Version Date: September 28, 2023
Public Version Number: 1
DI Record Publish Date: September 20, 2023