AccessGUDID - DEVICE: MRV6000LD - Therapeutic Phlebotomy Bag w/Needle (03567051503128)

GUDID

Device Identifier (DI) Information

Brand Name: MRV6000LD - Therapeutic Phlebotomy Bag w/Needle
Version or Model: MRV
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: MRV6000LD
Company Name: MACO PHARMA

Primary DI Number: 03567051503128
Issuing Agency: GS1
Commercial Distribution End Date: November 02, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 577149081 *Terms of Use

Device Description: 500 mL Phlebotomy Bag with Needle.

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?
44037	Blood donor set, triple-pack	An assembly of sterile devices intended to be used to collect whole blood from a donor and separate the red blood cells and plasma. It includes three containers (flexible bags) ? one or more with anticoagulation solution and/or preservatives for red blood cells, tubing, and an attached needle for venipuncture. It may include integrated features such as an in-line leukocyte filter, pre-donation blood sampling device, and/or needle stick prevention device. After collection, the red blood cells and plasma are separated, via centrifugation, into separate containers and subsequently tested, stored, and infused from the containers when needed. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAK	Microfilter, Blood Transfusion

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK030008	0

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a93ed5a4-c757-4d4d-ba7a-99e108569f7a
Public Version Date: March 13, 2025
Public Version Number: 6
DI Record Publish Date: September 22, 2016