AccessGUDID - DEVICE: FREND AP (08809317540467)

GUDID

Device Identifier (DI) Information

Brand Name: FREND AP
Version or Model: F10AP
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NanoEnTek, Inc.

Primary DI Number: 08809317540467
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 687910463 *Terms of Use

Device Description: No description.

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?
15105	Heating block IVD	An electrically-powered device which is primarily a heating element, with or without a thermostat, that is built into a compact block and intended to be used as a stable dry heat source to heat in vitro diagnostic specimens/laboratory materials. It is typically a stand-alone instrument, or an interchangeable component of an in vitro diagnostic instrument/analyser. It is available in various sizes to accommodate microplates of varying sizes, and may include covers to minimize evaporation from microplates.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JRG	Block, Heating

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9d239ab8-6536-42e2-9bca-8df62b42b044
Public Version Date: July 23, 2024
Public Version Number: 5
DI Record Publish Date: June 11, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

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: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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