AccessGUDID - DEVICE: BLOOD SAMPLE CONCENTRATOR KIT (08435389815570)

GUDID

Device Identifier (DI) Information

Brand Name: BLOOD SAMPLE CONCENTRATOR KIT
Version or Model: KIT BSC
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIOTECHNOLOGY INSTITUTE SL

Primary DI Number: 08435389815570
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 461665312 *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:	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?
63460	Fluid transfer tube, general-purpose	A sterile, flexible, blunt tubular device made of plastic materials designed to be used for the manual transfer of several types of medical fluids (e.g., solutions, syrups) between a first container (e.g., a vial) and a second container [e.g., a syringe]; it is not dedicated to a particular type of fluid or clinical procedure. It is not intended to puncture the seal of a vial/container, nor is it intended for patient contact. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJH	Clinical Sample Concentrator

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: Yes
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: 50aea5ab-76e8-487a-a9be-b98596f456aa
Public Version Date: June 21, 2023
Public Version Number: 1
DI Record Publish Date: June 13, 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: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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