AccessGUDID - DEVICE: Apheresis Needle with MASTERGUARD™ Protector (00811137012435)

GUDID

Device Identifier (DI) Information

Brand Name: Apheresis Needle with MASTERGUARD™ Protector
Version or Model: 4R2440
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 4R2440
Company Name: FENWAL, INC.

Primary DI Number: 00811137012435
Issuing Agency: GS1
Commercial Distribution End Date: June 09, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 794519020 *Terms of Use

Device Description: Apheresis Needle with MASTERGUARD™ Protector 16 Ga. x 1-1/4'' BE (Back Eye). Sterile Fluid Path.

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
FIE	Needle, Fistula

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: cc6ba833-e0f1-431e-8ccd-c8dd5cdcbb2b
Public Version Date: July 10, 2020
Public Version Number: 3
DI Record Publish Date: September 02, 2016