DEVICE: Playtex Baby (00094606810002)
Device Identifier (DI) Information
Playtex Baby
PL81000
Not in Commercial Distribution
Regent Baby Products Corp.
PL81000
Not in Commercial Distribution
Regent Baby Products Corp.
6pc. Healthcare Kit Includes: Nail Clippers, Nasal Aspirator, Medicine Dropper, Digital Thermometer, Medicine Spoon, and Travel Case.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
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.
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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 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
0074b0cd-da9d-443c-8bc0-56894fbd2958
May 01, 2023
2
March 29, 2022
May 01, 2023
2
March 29, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
7184656857
bkmitch@babyking.com
bkmitch@babyking.com