AccessGUDID - DEVICE: Marina Medical (00840306835049)

GUDID

Device Identifier (DI) Information

Brand Name: Marina Medical
Version or Model: 800-010S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 800-010S
Company Name: MARINA MEDICAL INSTRUMENTS, INC.

Primary DI Number: 00840306835049
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 011442279 *Terms of Use

Device Description: 10cc Syringe Holder for Manual Centrifuge, Short Shaft

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:	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: 1128d364-3452-4f00-998b-9dd594fd8325
Public Version Date: January 22, 2025
Public Version Number: 2
DI Record Publish Date: December 11, 2024