AccessGUDID - DEVICE: Medisystems TwinPack Hemodialysis Fistula Needle Set with MasterGuard Plus (00842289101791)

GUDID

Device Identifier (DI) Information

Brand Name: Medisystems TwinPack Hemodialysis Fistula Needle Set with MasterGuard Plus
Version or Model: D9-2006MGP
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MEDISYSTEMS CORPORATION

Primary DI Number: 00842289101791
Issuing Agency: GS1
Commercial Distribution End Date: August 26, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 061310132 *Terms of Use

Device Description: MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 16G X 1" WITH MASTERGUARD PLUS INCLUDED WITH TWINPACK D9-2006MGP

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":	Yes
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?
12741	Haemodialysis needle	A sterile, sharp bevel-edged, hollow tubular metal instrument used to remove and return a patient's blood during a haemodialysis procedure. Commonly known as a dialysis needle. 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
Special Storage Condition, Specify: Keep dry
Storage Environment Temperature: between 0 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 1 Inch
Needle Gauge: 16 Gauge

Device Record Status

Public Device Record Key: 8ca6b6af-ab38-4906-9f18-f9ed343483a0
Public Version Date: August 27, 2020
Public Version Number: 3
DI Record Publish Date: October 26, 2017