Profi disposable syringe

GUDID 18800109001590

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.

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Primary Device ID	18800109001590
NIH Device Record Key	e07dc5b1-3aa9-42d5-aa46-5e678c700acc
Commercial Distribution Status	In Commercial Distribution
Brand Name	Profi disposable syringe
Version Model Number	Profi LDS syringe 1mL 26G×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	08800109001593 [Primary]
GS1	18800109001590 [Package] Contains: 08800109001593 Package: Inner box [100 Units] In Commercial Distribution
GS1	28800109001597 [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

[18800109001590]

Ethylene Oxide

[18800109001590]

Ethylene Oxide

[18800109001590]

Ethylene Oxide

[18800109001590]

Ethylene Oxide

[18800109001590]

Ethylene Oxide

[18800109001590]

Ethylene Oxide

[18800109001590]

Ethylene Oxide

[18800109001590]

Ethylene Oxide

[18800109001590]

Ethylene Oxide

[18800109001590]

Ethylene Oxide

[18800109001590]

Ethylene Oxide

[18800109001590]

Ethylene Oxide

[18800109001590]

Ethylene Oxide

[18800109001590]

Ethylene Oxide

[18800109001590]

Ethylene Oxide

[18800109001590]

Ethylene Oxide

[18800109001590]

Ethylene Oxide

[18800109001590]

Ethylene Oxide

[18800109001590]

Ethylene Oxide

[18800109001590]

Ethylene Oxide

[18800109001590]

Ethylene Oxide

[18800109001590]

Ethylene Oxide

[18800109001590]

Ethylene Oxide

[18800109001590]

Ethylene Oxide

[18800109001590]

Ethylene Oxide

[18800109001590]

Ethylene Oxide

[18800109001590]

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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