AccessGUDID - DEVICE: 8001 Series Skin Temperature Probe (H29780010634010)

GUDID

Device Identifier (DI) Information

Brand Name: 8001 Series Skin Temperature Probe
Version or Model: 8001-063-401
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8001-063-401
Company Name: MEASUREMENT SPECIALTIES, INC.

Primary DI Number: H29780010634010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 029351079 *Terms of Use

Device Description: 8001 Series Skin 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:	Yes
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?
35254	General-purpose patient temperature probe, single-use	A temperature sensing device intended to be placed into a body orifice or on the body surface, and used in conjunction with a separate parent device with a display (e.g., electronic patient thermometer, infant warmer) to enable measurement/monitoring of a patient’s temperature; its use is not dedicated to a specific type of procedure. It is typically constructed of flexible materials (e.g., plastic or rubber) with a metal conducting core; the distal end of different device types will be designed for a particular application site. This is a single-use device.	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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -5 and 55 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d87d370b-e131-4340-bb5f-791aae40fc5f
Public Version Date: October 19, 2018
Public Version Number: 3
DI Record Publish Date: July 01, 2016