AccessGUDID - DEVICE: BIOBASE (06936895300106)

GUDID

Device Identifier (DI) Information

Brand Name: BIOBASE
Version or Model: OLB-12X
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Biobase Biodustry(Shandong)Co., Ltd.

Primary DI Number: 06936895300106
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 420046355 *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):	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?
17489	Microplate washer IVD	An electrically-powered automated or semi-automated laboratory instrument intended to be used for washing microplates containing multiple individual sample wells (i.e., the removal of biological specimen residue, stains, or impurities) by dispensing and aspirating measured volumes of washing solution as part of the processing required to perform an in vitro diagnostic assay.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JTC	Device, Microtiter Diluting/Dispensing

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: bb7b9e66-7ba3-43fb-8da4-522eae194d0e
Public Version Date: July 13, 2023
Public Version Number: 1
DI Record Publish Date: July 05, 2023

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

Customer Contact

[?]

No Customer Contact currently defined

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