AccessGUDID - DEVICE: JMS HARMONY A.V.FISTULA NEEDLE SET (08888483005482)

GUDID

Device Identifier (DI) Information

Brand Name: JMS HARMONY A.V.FISTULA NEEDLE SET
Version or Model: 827-1503-33
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: JMS SINGAPORE PTE LTD

Primary DI Number: 08888483005482
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 595159278 *Terms of Use

Device Description: HARMONY A.V.FISTULA 15GX1" BE 40CM W/CLAMP

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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
Handling 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: a5c794fb-1200-4eb2-aa66-a4fe4dbd8f54
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 23, 2016