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Profi disposable syringe

FDA UDI

Class II (US FDA UDI)

by Shinchang Medical Co., Ltd.

Identity

Trade Name
Profi disposable syringe FDA UDI
Generic Name
General-purpose syringe, single-use FDA UDI
Device Name
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 FDA UDI
Model / Reference
Profi LDS syringe 1mL 26G×1" FDA UDI
Description
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 FDA UDI

Identifiers

Primary DI / UDI-DI
08800109001593 FDA UDI
510(k) Number
K993017 FDA UDI
FDA Product Code
FMF FDA UDI
GMDN Term
General-purpose syringe, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5860 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Category: General-purpose syringe, single-use

Profi disposable syringe by Shinchang Medical Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General-purpose syringe, single-use.

Cleared under the same submission

K993017 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Shinchang Medical Co., Ltd.

Sources (1)

  • FDA UDI e07dc5b1-3aa9-42d5-aa46-5e678c700acc 35 fields · synced May 30, 2026