Profi disposable syringe

Primary DI
18800109050611
Brand
Profi disposable syringe
Company
Shinchang Medical Co., Ltd.
Model
Profi disposable syringe 5mL 23G×1"
Device 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
Published
2021-05-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K993017000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K993017000PROFI DISPOSABLE SYRINGE, PROFI DISPOSABLE NEEDLE, DM JECT INSULIN SYRINGEShinchang Medical Co., Ltd.2000-02-25FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18800109050611PackageGS1100In Commercial Distribution
28800109050618PackageGS11600In Commercial Distribution
08800109050614PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1880010905061118800109050611
2880010905061828800109050618
08800109050614088001090506148800109050614

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose syringe, single-useA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
631088403
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800109007038DMject Insulin Syringe"DMject Insulin Syringe 0.3mL 30G×5/16"""2026-03-03
08800109007076DMject Insulin Syringe"DMject Insulin Syringe 0.5mL 30G×5/16"""2026-03-03
08800109007120DMject Insulin Syringe"DMject Insulin Syringe 1mL 31G×5/16"""2026-03-03
18800109007035DMject Insulin SyringeDMject Insulin Syringe 0.3mL 30G×5/16"2026-03-03
18800109007073DMject Insulin SyringeDMject Insulin Syringe 0.5mL 30G×5/16"2026-03-03
18800109007127DMject Insulin SyringeDMject Insulin Syringe 1mL 31G×5/16"2026-03-03
08800109000015Profi disposable syringe"Profi disposable syringe 1mL 23G×1"""2021-02-23
08800109000411Profi disposable syringe"Profi disposable syringe 3mL 23G×1"""2021-02-23
08800109000619Profi disposable syringe"Profi disposable syringe 5mL 23G×1"""2021-04-14
08800109001579Profi disposable syringe"Profi LDS syringe 1mL 23G×1"""2021-05-20
08800109001586Profi disposable syringe"Profi LDS syringe 1mL 25G×1"""2021-05-20
08800109001593Profi disposable syringe"Profi LDS syringe 1mL 26G×1"""2021-05-20
08800109050010Profi disposable syringe"Profi disposable syringe 1mL 23G×1"""2021-01-29
08800109050416Profi disposable syringe"Profi disposable syringe 3mL 23G×1"""2021-05-04
08800109050614Profi disposable syringe"Profi disposable syringe 5mL 23G×1"""2021-05-04
18800109001576Profi disposable syringeProfi LDS syringe 1mL 23G×1"2021-05-20
18800109001583Profi disposable syringeProfi LDS syringe 1mL 25G×1"2021-05-20
18800109001590Profi disposable syringeProfi LDS syringe 1mL 26G×1"2021-05-20
18800109050413Profi disposable syringeProfi disposable syringe 3mL 23G×1"2021-05-04
18800109000616Profi disposable syringeProfi disposable syringe 5mL 23G×1"2021-04-14

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