DEVICE: Profi disposable syringe (08800109000619)
Device Identifier (DI) Information
Profi disposable syringe
Profi disposable syringe 5mL 23G×1"
In Commercial Distribution
Shinchang Medical Co., Ltd.
Profi disposable syringe 5mL 23G×1"
In Commercial Distribution
Shinchang Medical Co., Ltd.
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
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
47017 | General-purpose syringe, single-use |
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 needle is not included. It is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It 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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FMF | Syringe, Piston |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K993017 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 0 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
e512b33c-f2a9-4c89-82cf-053cdd46ba99
March 11, 2024
2
April 14, 2021
March 11, 2024
2
April 14, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
18800109000616 | 100 | 08800109000619 | In Commercial Distribution | Inner box | |
28800109000613 | 1600 | 18800109000616 | In Commercial Distribution | Outer box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined