AccessGUDID - DEVICE: AccuTemp Probe (10817522010236)

GUDID

Device Identifier (DI) Information

Brand Name: AccuTemp Probe
Version or Model: 232H
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 232H
Company Name: KENTEC MEDICAL, INC.

Primary DI Number: 10817522010236
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 066175613 *Terms of Use

Device Description: OHMEDA GIRAFFE OMNI-BED COMPATIBLE TEMP.PROBE w/hydrogel 175 probe cover

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?
36989	Environmental sensor	An electronic device designed to be used to monitor the conditions of a specific environment. It may be used to monitor environmental parameters such as air temperature, relative humidity, or atmospheric oxygen concentration. This device, designed as a cable/lead with a sensor at the distal end and a connecting plug (e.g., a jack plug) at its proximal end, is used with a parent device that requires environmental monitoring, e.g., an infant incubator, or with a dedicated monitoring device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMT	Warmer, Infant Radiant

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K960080	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7a37fbe4-629e-4acf-826a-60049b6cbdcf
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 02, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20817522010233	10	10817522010236		In Commercial Distribution	box

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

[?]

Phone: 949-863-0810
Email: kjrooks@kentecmedical.com

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