AccessGUDID - DEVICE: TempaDOT (00016944301066)

GUDID

Device Identifier (DI) Information

Brand Name: TempaDOT
Version or Model: 5192R
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TD Plus F
Company Name: MEDICAL INDICATORS INC

Primary DI Number: 00016944301066
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 030104165 *Terms of Use

Device Description: TempaDOT Plus F single use Clinical Thermometer with Rectal Sheath

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:	Yes
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?
35899	Colour-indication patient thermometer	A device designed to measure a patient's skin, oral, rectal, or axillary (armpit) body temperature. The device records body temperature using heat sensitive chemical cells (dots) which are sealed at the end of a plastic or metal strip. Body heat causes a colour change in the heat sensitive chemicals. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FQZ	Thermometer, Clinical Color Change

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
Storage Environment Temperature: less than 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Weight: 0.0022 Pound

Device Record Status

Public Device Record Key: 3c991d71-b7cf-4319-8545-c803c82273b0
Public Version Date: August 23, 2023
Public Version Number: 2
DI Record Publish Date: May 29, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20016944301060	1600	00016944301066		In Commercial Distribution	Case

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: 10016944301063 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: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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