AccessGUDID - DEVICE: Terumo (16930197851790)

GUDID

Device Identifier (DI) Information

Brand Name: Terumo
Version or Model: SENG-03L2525R
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Shanghai Kindly Enterprise Development Group Co.,Ltd.

Primary DI Number: 16930197851790
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 530462431 *Terms of Use

Device Description: Hypodermic Syringe with Safety Needle 3ml 25G×1“

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?
63095	General-purpose syringe/needle	A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a non-retractable needle is included, either attached or detached (usually capped for user protection). It is intended for various medical applications and is not dedicated to medication administration. The syringe is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MEG	Syringe, Antistick
FMF	Syringe, Piston
FMI	Needle, Hypodermic, Single Lumen

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K221416	000

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: 7ea83536-5e50-4dff-a73c-33645b73fc91
Public Version Date: March 08, 2023
Public Version Number: 1
DI Record Publish Date: February 28, 2023