Profi disposable syringe

GUDID 18800109001576

1. Disposable Syringe 2. Intended use : To inject fluids into or withdraw fluids out of the body. 3. Instructions for use 1) Expose needle by removing needle cover. 2) Inject the fluid into syringe by pulling plunger 3) After injecting the injection fluid into the syringe, inject into disinfected area by pushing plunger. 4) After injecting the fluid into the affected area, withdraw the syringe from needle and dispose immediately("Do not reuse") 4. Warning 1) This product is single use device, therefore it must be disposed after its use 2) Do not reuse after suction the medicines. 3) Do not use individual packages that are opened or damaged because sterilization is not guaranteed. 4) Do not use damaged or bent needle before use. 5) Do not use the product when it finds foreign substances before use 6) To prevent secondary contamination, open the package before use. 7) Do not use the product except general injection purposes. 8) Do not attempt to close the needle cover after use. If you are pierced by contaminated needle, various infections can infected 5. Storage Avoid direct sunlight and store at room temperature in a dry and clean place. 6. Caution Federal law restricts this device to sale by or on the order of a physician. 7. Expiry Date : 3 years from manufacturing date

Shinchang Medical Co., Ltd.

General-purpose syringe, single-use

• Primary Device ID: 18800109001576
• NIH Device Record Key: 5df75733-dd6e-4839-9e80-82381db23606
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Profi disposable syringe
• Version Model Number: Profi LDS syringe 1mL 23G×1"
• Company DUNS: 631088403
• Company Name: Shinchang Medical 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800109001579 [Primary]
GS1	18800109001576 [Package]; Contains: 08800109001579; Package: Inner box [100 Units]; In Commercial Distribution
GS1	28800109001573 [Package]; Package: Outer box [3000 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993017

FDA Product Code

• FMF: Syringe, Piston

Sterilization

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

[18800109001576]

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[18800109001576]

Ethylene Oxide

[18800109001576]

Ethylene Oxide

[18800109001576]

Ethylene Oxide

[18800109001576]

Ethylene Oxide

[18800109001576]

Ethylene Oxide

[18800109001576]

Ethylene Oxide

[18800109001576]

Ethylene Oxide

[18800109001576]

Ethylene Oxide

[18800109001576]

Ethylene Oxide

[18800109001576]

Ethylene Oxide

[18800109001576]

Ethylene Oxide

[18800109001576]

Ethylene Oxide

[18800109001576]

Ethylene Oxide

[18800109001576]

Ethylene Oxide

[18800109001576]

Ethylene Oxide

[18800109001576]

Ethylene Oxide

[18800109001576]

Ethylene Oxide

[18800109001576]

Ethylene Oxide

[18800109001576]

Ethylene Oxide

[18800109001576]

Ethylene Oxide

[18800109001576]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-28
• Device Publish Date: 2021-05-20

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• 18800109000616: 1. Disposable Syringe 2. Intended use : To inject fluids into or withdraw fluids out of the body
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• 18800109001583: 1. Disposable Syringe 2. Intended use : To inject fluids into or withdraw fluids out of the body
• 18800109001576: 1. Disposable Syringe 2. Intended use : To inject fluids into or withdraw fluids out of the body