Playtex Baby

Basic Information

• Brand Name: Playtex Baby
• Primary DI: 00094606810002
• Version / Model: PL81000
• Company Name: Regent Baby Products Corp.
• Labeler DUNS: 005910997
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-03-29
• Public Version: 2
• Public Version Date: 2023-05-01
• Public Version Status: Update
• Public Device Record Key: 0074b0cd-da9d-443c-8bc0-56894fbd2958
• Distribution End Date: 2023-04-29

Device Description

6pc. Healthcare Kit Includes: Nail Clippers, Nasal Aspirator, Medicine Dropper, Digital Thermometer, Medicine Spoon, and Travel Case.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FLL	Thermometer, Electronic, Clinical	General Hospital	880.2910	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17436	Laboratory thermometer	An electronic measuring instrument used in the laboratory to measure and establish the level of a temperature in an object, matter, or medium. It is designed for use in the laboratory for temperatures over a wide or particular range. It will have a high degree of accuracy and typically use a thermistor sensor for uptake of the measurement. It is typically used to verify that: 1) devices, e.g., water baths, heated cells or refrigerators, operate within the prescribed temperature limits; and 2) material, e.g., liquids, gases or semi-solids, have reached a desired temperature. For devices intended to measure the body temperature of patients see the appropriate GMDN code.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00094606810002	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]