AccessGUDID - DEVICE: Marina Medical (00840306809545)

GUDID

Device Identifier (DI) Information

Brand Name: Marina Medical
Version or Model: 800-000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 800-000
Company Name: MARINA MEDICAL INSTRUMENTS, INC.

Primary DI Number: 00840306809545
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 011442279 *Terms of Use

Device Description: Manual Centrifuge, Non-Autoclavable

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:	No
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?
62648	Blood component separator, manual	A manually-operated device designed for the separation of previously centrifuged blood into components [e.g., red blood cells (RBCs), plasma, platelets] for further processing or storage. It is a compact mechanical unit (non-powered) that uses pressure plates to facilitate the transfer of each component from the donor bag into a respective collection bag. It is typically used in a blood bank or transfusion centre, and is not donor or patient connected.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MDM	INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 9f3138ec-62a4-4133-880f-81261ab9baf8
Public Version Date: December 12, 2022
Public Version Number: 2
DI Record Publish Date: November 10, 2022