AccessGUDID - DEVICE: JMS SYSLOC MINI A.V. FISTULA NEEDLE SET (08888483006007)

GUDID

Device Identifier (DI) Information

Brand Name: JMS SYSLOC MINI A.V. FISTULA NEEDLE SET
Version or Model: 864-1504
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: JMS SINGAPORE PTE LTD

Primary DI Number: 08888483006007
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 595159278 *Terms of Use

Device Description: SYSLOC MINI AVF 15GX11/4" BE 30CM W/CLAMP

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?
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
Storage Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Handling Environment Temperature: between 5 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Needle Gauge: 15 Gauge

Device Record Status

Public Device Record Key: a3e5d2ac-964d-4233-8e85-01a2c4db5c28
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: June 27, 2017