AccessGUDID - DEVICE: TempAlert II (30815236020323)

GUDID

Device Identifier (DI) Information

Brand Name: TempAlert II
Version or Model: 8501-II-CE
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8501-II-CE
Company Name: LCR HALLCREST, LLC.

Primary DI Number: 30815236020323
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 059247507 *Terms of Use

Device Description: TempAlert II Liquid Crystal Temperature Trend Indicator - CE Marked

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):	Yes
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?
33618	Liquid-crystal patient thermometer, single-use	A device designed to measure a patient's skin, oral, rectal, or axillary (armpit) body temperature. It uses liquid-crystal sensors (usually formed from esters of cholesterol) that are sealed in a plastic band and appear to change colour at indicated temperatures. The device may be used in the home. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KPD	Strip, Temperature, Forehead, Liquid Crystal

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
Special Storage Condition, Specify: Optimal Storage and Handling Conditions: 60 to 80°F and 40 to 60% relative humidity
Storage Environment Temperature: between 60 and 104 Degrees Fahrenheit
Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0744809f-66c0-4034-a9b8-bbc8769740b9
Public Version Date: November 03, 2020
Public Version Number: 1
DI Record Publish Date: October 26, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
40815236020320	1	30815236020323		In Commercial Distribution	Outer Box

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: 00815236020322 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

[?]

Phone: 1-800-325-3671
Email: mailbox@sharn.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES