AccessGUDID - DEVICE: VitaPrep (00808232001242)

GUDID

Device Identifier (DI) Information

Brand Name: VitaPrep
Version or Model: 2113-0013
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 2113-0013
Company Name: Stryker Corporation

Primary DI Number: 00808232001242
Issuing Agency: GS1
Commercial Distribution End Date: June 30, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 149183167 *Terms of Use

Device Description: Plasma Separator

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
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?
45669	Blood centrifugation system containment kit	A collection of sterile devices that is a component of a blood centrifugation system intended to be used during the centrifugation of blood, relative components or cellular products (e.g., umbilical cord blood, bone marrow), to automatically isolate constituent components (e.g., cells, plasma). The kit is not donor or patient connected and is placed in the centrifuge of the processing unit. It includes a centrifugation chamber into which blood is introduced and sedimented into its components during centrifugation, a stopcock manifold and tubing intended to direct and control the sequential movement of each component, and collection containers. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LMF	Agent, absorbable hemostatic, collagen based

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P050044	019
P050044	026

Device Exempt from Premarket Submission: No 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
Storage Environment Temperature: between 20 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d6aa766b-49d9-4310-8f8b-1cd79d10d1c2
Public Version Date: April 23, 2019
Public Version Number: 3
DI Record Publish Date: September 24, 2014