AccessGUDID - DEVICE: PCRopsis (B5508880010)

GUDID

Device Identifier (DI) Information

Brand Name: PCRopsis
Version or Model: Universal Viral Transport
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 888001
Company Name: ENTOPSIS, LLC

Primary DI Number: B5508880010
Issuing Agency: HIBCC
Commercial Distribution End Date: December 01, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 078294784 *Terms of Use

Device Description: PCRopsis™ Universal Viral Transport is intended for the collection and non-propagating transport of clinical specimens containing viruses, chlamydiae, mycoplasmas or ureaplasmas from the collection site to the testing laboratory.

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?
58697	Viral transport medium IVD	A vessel containing transport medium intended to be used for the preservation and transport of viral culture isolates from a clinical specimen.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
JSM	Culture Media, Non-Propagating Transport

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: 5e8bf86d-132b-4965-a99b-cbc96ae59eab
Public Version Date: March 18, 2021
Public Version Number: 2
DI Record Publish Date: September 08, 2020