Syringe with needle T1ML2325E

GUDID 16958697602681

A sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. The application of the content of this device may be in conjunction with an injector device (transcutaneous delivery) or through the traditional use of a needle (subcutaneous delivery). It may allow for retraction of an attached needle (safety syringe); the needle is not included. This is a single-use device.

ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTD

Metered-delivery hypodermic syringe

• Primary Device ID: 16958697602681
• NIH Device Record Key: 273b45b0-5317-4be7-9ea1-98b905015a85
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Syringe with needle
• Version Model Number: LS-1ml 23G X 1"
• Catalog Number: T1ML2325E
• Company DUNS: 543007373
• Company Name: ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06958697602684 [Primary]
GS1	16958697602681 [Package]; Contains: 06958697602684; Package: [100 Units]; In Commercial Distribution
GS1	26958697602688 [Package]; Package: [32 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190183

FDA Product Code

• MEG: Syringe, Antistick

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-07
• Device Publish Date: 2021-03-30

On-Brand Devices [Syringe with needle]

• 16958697602421: A sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to
• 16958697602520: A sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to
• 16958697602568: A sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to
• 16958697602551: A sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to
• 16958697602544: A sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to
• 16958697602537: A sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to
• 16958697602681: A sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to
• 16958697602629: A sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to
• 16958697602605: A sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to
• 16958697602599: A sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to
• 16958697602742: A sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to
• 16958697602810: A sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to
• 16958697602803: A sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to
• 16958697602797: A sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to
• 16958697602872: A sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to