AccessGUDID - DEVICE: ProGen PC Kit (00861122000312)

GUDID

Device Identifier (DI) Information

Brand Name: ProGen PC Kit
Version or Model: BELL-82380-A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BELL-82380-A
Company Name: CELLMEDIX HOLDINGS, LLC

Primary DI Number: 00861122000312
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080357711 *Terms of Use

Device Description: The ProGen PC design concept is predicated on providing an easy to use device for platelet rich plasma (PRP) that demonstrates high platelet yield in a highly reproducible manner. This is accomplished by inclusion of design elements that provide appropriate directional, and selectable, cell layer aspiration within the horizontally dispersed “buffy coat” in the centrifuge tube design. The design resembles the shape, and general construction, of a standard 50ml centrifuge tube, but differs from such standard products by inclusion of proprietary structural components. The similarities in design allow such devices to be centrifuged in any tabletop centrifuge that accepts a 50ml tube and is, additionally, capable of 1900 RCF at 3500 RPM, 4X50ml capacity and 30-minute timer.

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:	Yes
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?
46923	Haematological concentrate system preparation kit, platelet concentration	A collection of devices designed to prepare platelet-rich plasma (PRP) or platelet-rich fibrin matrix (PRFM) from an autologous blood specimen for application to soft-tissue wounds and injured bone to accelerate healing and/or achieve haemostasis. It includes single- or double- (concentric) barrel syringe(s) with connecting tubes and caps. Blood is collected by venous puncture and processed in a centrifuge, increasing the concentration of platelets within the plasma or fibrin matrix; this may be done at the point-of-care. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ORG	Platelet And Plasma Separator For Bone Graft Handling

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK130079	0

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

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: 7f0c59c8-cd07-4cea-afd5-d19df00403d2
Public Version Date: July 23, 2020
Public Version Number: 5
DI Record Publish Date: December 21, 2016