Duns Number:631088403
Device Description: 1. Disposable Syringe2. Intended use : To inject fluids into or withdraw fluids out of the 1. Disposable Syringe2. Intended use : To inject fluids into or withdraw fluids out of the body.3. Instructions for use1) Expose needle by removing needle cover.2) Inject the fluid into syringe by pulling plunger3) 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. Warning1) 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 use6) 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 infected5. StorageAvoid direct sunlight and store at room temperature in a dry and clean place.6. CautionFederal law restricts this device to sale by or on the order of a physician.7. Expiry Date : 3 years from manufacturing date
Catalog Number
-
Brand Name
Profi disposable syringe
Version/Model Number
Profi LDS syringe 1mL 25G×1"
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
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Device labeled as "Not made with natural rubber latex"
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For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
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Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
c761e7c7-c18a-486e-964d-e8ca371a7782
Public Version Date
May 28, 2021
Public Version Number
1
DI Record Publish Date
May 20, 2021
Package DI Number
18800109001583
Quantity per Package
100
Contains DI Package
08800109001586
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner box