AccessGUDID - DEVICE: Prochem (00860002864853)

GUDID

Device Identifier (DI) Information

Brand Name: Prochem
Version or Model: BJP-10/100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BJP-10/100
Company Name: VIVAPRODUCTS, INC.

Primary DI Number: 00860002864853
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 859690476 *Terms of Use

Device Description: BJP PROTEIN CONCENTRATOR 10ml, 100 TESTS

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):	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?
58385	Evaporation/filtration sample concentrator	A mains electricity (AC-powered) laboratory device designed to concentrate fluid containing solutes (dissolved substances, including salts and proteins/hormones) or other chemical compounds (drugs or toxins) by removing the water element. It typically uses heat (to encourage evaporation), membranes, or other small-pore filters that only enable the transmission of water (either by osmotic transfer or sheer physical size of the compounds, with or without the assistance of added pressure via a pump or vacuum) to reduce the fluid component. Some types may employ low pressure gas distributed via a manifold that is blown onto the fluid surface of the solution (to encourage solvent evaporation).	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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 10 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: eccef020-8d5c-4530-ab68-c062f8ac87b3
Public Version Date: October 08, 2020
Public Version Number: 1
DI Record Publish Date: September 30, 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: 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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