AccessGUDID - DEVICE: Shifeng (G001S10000)

GUDID

Device Identifier (DI) Information

Brand Name: Shifeng
Version or Model: S-1000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.

Primary DI Number: G001S10000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 529534554 *Terms of Use

Device Description: No description.

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):	No
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?
35387	Anaesthesia Luer syringe	A device consisting of a calibrated barrel (cylinder) with plunger intended to be used to administer (infuse) anaesthetic drugs. At the distal end of the barrel is a male Luer connector (typically a Luer-lock type) for the attachment of the female connector (hub) of a hypodermic needle, administration set or dental syringe cannula. It is typically made of plastic and silicone materials and may have anti-stick properties (internally precoated with compatible substances) that allow the plunger to move smoothly. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMF	Syringe, Piston

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: c9891ba9-e462-4b64-ac0b-beb3b28f5213
Public Version Date: February 20, 2023
Public Version Number: 3
DI Record Publish Date: December 01, 2020