AccessGUDID - DEVICE: HEPRO.US - Gel & Clot Activator Tube (00850578007631)

GUDID

Device Identifier (DI) Information

Brand Name: HEPRO.US - Gel & Clot Activator Tube
Version or Model: Pack Gel Clot Test Tubes
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HEPRO.US INC.

Primary DI Number: 00850578007631
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 080061451 *Terms of Use

Device Description: Gel & Clot Activator Tube, with serum for determinations in chemistry and serology. Pack of 100

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
14189	Culture tube	A sterile glass or plastic tube-like container used to hold a culture specimen. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection

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: afb15344-46df-4ea1-99d8-363b54fbf9e9
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: June 21, 2017