AccessGUDID - DEVICE: TENDIGO (05414470804122)

GUDID

Device Identifier (DI) Information

Brand Name: TENDIGO
Version or Model: 80412
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Fujirebio Europe

Primary DI Number: 05414470804122
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 297346645 *Terms of Use

Device Description: Instrument

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):	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?
62957	Blot processor IVD	A mains electricity (AC-powered) laboratory instrument intended to be used for the processing of a prepared clinical specimen with an immobilized probe on a solid phase (e.g. blotting membrane or gel sheet) for blot assays (e.g. line assays, Western, Southern and/or Northern blot). It typically performs pre-analytical steps including (but not limited to) reagent dispensing, incubation (with or without heating), agitation and washing. The device does not include a detector and is not intended to perform qualitative and/or quantitative measurements.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

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
Handling Environment Temperature: between 15 and 30 Degrees Celsius
Storage Environment Temperature: between -25 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 27 Inch
Width: 18 Inch
Height: 15 Inch

Device Record Status

Public Device Record Key: 023d5073-6e02-4b57-9305-b23b2d5bf104
Public Version Date: October 04, 2023
Public Version Number: 2
DI Record Publish Date: February 24, 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
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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +32093291329
Email: info@fujirebio.com

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