AccessGUDID - DEVICE: BIOS Diagnostics (00057475220495)

GUDID

Device Identifier (DI) Information

Brand Name: BIOS Diagnostics
Version or Model: 220DI
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Thermor Ltd

Primary DI Number: 00057475220495
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 246883458 *Terms of Use

Device Description: Glass 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?
64142	Capillary patient thermometer, gallium-alloy	An instrument designed to measure a patient's body temperature which is formed as a slender, hollow, sealed tube made of glass with a bulb at one end filled with a non-toxic liquid gallium alloy (typically alloyed with indium and tin). It works on the capillary principle whereby the registered heat proportionally expands the medium, filling a graduated column. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FLK	Thermometer, Clinical Mercury

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: 1ff08163-9f95-4741-b117-82a7f8a2b606
Public Version Date: September 28, 2023
Public Version Number: 1
DI Record Publish Date: September 20, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10057475220492	6	00057475220495		In Commercial Distribution	Case
80057475220491	4	10057475220492		In Commercial Distribution

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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