AccessGUDID - DEVICE: TEMPERATURE PROBE (08426950452614)

GUDID

Device Identifier (DI) Information

Brand Name: TEMPERATURE PROBE
Version or Model: 06320480210
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 06320480210
Company Name: INSTRUMENTATION LABORATORY COMPANY

Primary DI Number: 08426950452614
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 557223252 *Terms of Use

Device Description: TEMPERATURE PROBE

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):	Yes
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?
56690	Coagulation analyser IVD, laboratory, semi-automated	A mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of one or multiple coagulation components involved in haemostasis in a clinical specimen [e.g., performs tests such as prothrombin time (PT), partial thromboplastin time (PTT)]. Analyser design may incorporate spectrophotometry, turbidimetry, nephelometry, electrometry, electromagnetic and/or mechanical means of clot formation or end point detection. The device operates with reduced technician involvement and automation of some, but not all, procedural steps.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
JKS	Spectral absorb. Curve, oxyhemoglobin, carboxyhemoglobin, carbon-monoxide

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K951485	000

Device Exempt from Premarket Submission: No 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: between 15 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6db56f61-309b-42a0-be9c-10edda1cfa3a
Public Version Date: July 14, 2021
Public Version Number: 7
DI Record Publish Date: September 23, 2016