AccessGUDID - DEVICE: HAEMONETICS MCS+ (LN9000) APHERESIS SYSTEM (10812747012089)

GUDID

Device Identifier (DI) Information

Brand Name: HAEMONETICS MCS+ (LN9000) APHERESIS SYSTEM
Version or Model: 00981-00
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HAEMONETICS CORPORATION

Primary DI Number: 10812747012089
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 057827420 *Terms of Use

Device Description: TPE Disposable,125mLLathamBwl

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:	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?
47572	Apheresis system tubing set	A collection of sterile, flexible, plastic tube segments and associated items (e.g., connectors, line clamp, drip chamber) intended to be used in an apheresis system to channel blood from the patient to an appropriate apheresis column before being returned to the patient. It creates a closed-circuit for the extracorporeal removal of a constituent of whole blood (e.g., leukocytes, plasma). The channeling of apheresis solutions for the priming, regeneration, preservation of columns before or after an apheresis procedure may also be through the tubing set. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LKN	SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K953681	000

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
Total Volume: 125 Milliliter

Device Record Status

Public Device Record Key: 10be34c2-a632-451a-997c-507e4099c229
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: February 08, 2017