MEDEFIL, INC.

Address:250 WINDY POINT DR.,GLENDALE HEIGHTS,IL,60139,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Heparin, Vascular Access Flush (NZW) (10)

Premarket Exempt

Clear

Medefil Heparin Lock Flush Syringe, 100 Unit/mL - 30364253333300 Catalog Number : MIH-3330

Device Description : Medefil Heparin Lock Flush Syringe, 100 Unit/mL, 10mL in 12mL Syringe, Does not Medefil Heparin Lock Flush Syringe, 100 Unit/mL, 10mL in 12mL Syringe, Does not contain natural rubber latex or preservatives. Contents and its pathway are sterile. Single use.

Device Class :

Duns Number: 016448669

Premarket Exempt : No

Product Code : NZW

Prescription Use : Yes

Device Count : 16

Heparin Lock Flush Syringe 100 Units/mL - 30364253333331 Catalog Number : MIH-3333

Device Description : Heparin Lock Flush Syringe 100 Units/mL, 3 mL fill in 12 mL syringe, Does not c Heparin Lock Flush Syringe 100 Units/mL, 3 mL fill in 12 mL syringe, Does not contain natural rubber latex or preservatives, Contents and its pathway are sterile, Single Use

Device Class :

Duns Number: 016448669

Premarket Exempt : No

Product Code : NZW

Prescription Use : Yes

Device Count : 60

Heparin Lock Flush Syringe 100 Units/mL - 30364253333355 Catalog Number : MIH-3335

Device Description : Heparin Lock Flush Syringe 100 Units/mL, 5 mL fill in 12 mL syringe, Does not co Heparin Lock Flush Syringe 100 Units/mL, 5 mL fill in 12 mL syringe, Does not contain natural rubber latex or preservatives, Contents and its pathway are sterile, Single Use

Device Class :

Duns Number: 016448669

Premarket Exempt : No

Product Code : NZW

Prescription Use : Yes

Device Count : 60

Medefil Lock Flush Syringe, 1000 Unit/mL - 30364253333522 Catalog Number : MIH-3352

Device Description : Medefil Heparin Lock Flush Syringe, 100 Unit/mL, 2.5mL in 6mL Syringe, Does not Medefil Heparin Lock Flush Syringe, 100 Unit/mL, 2.5mL in 6mL Syringe, Does not contain natural rubber latex or preservatives. Contents and its pathway are sterile. Single use.

Device Class :

Duns Number: 016448669

Premarket Exempt : No

Product Code : NZW

Prescription Use : Yes

Device Count : 60

Medefil Heparin Lock Flush Syringe, 1 Unit/mL - 30364253444211 Catalog Number : MIH-4421

Device Description : Medefil Heparin Lock Flush Syringe, 1 Unit/mL, 1mL in 6mL Syringe, Does not cont Medefil Heparin Lock Flush Syringe, 1 Unit/mL, 1mL in 6mL Syringe, Does not contain natural rubber latex or preservatives. Contents and its pathway are sterile. Single use.

Device Class :

Duns Number: 016448669

Premarket Exempt : No

Product Code : NZW

Prescription Use : Yes

Device Count : 60

Heparin Lock Flush Syringe 1 unit/mL - 30364253444228 Catalog Number : MIH-4422

Device Description : Medefil 1 Unit /mL Heparin Lock Flush Syringe, 2mL fill in 6mL syringe, Does not Medefil 1 Unit /mL Heparin Lock Flush Syringe, 2mL fill in 6mL syringe, Does not contain natural rubber latex or preservatives, Contents and its pathway are sterile, Single Use

Device Class :

Duns Number: 016448669

Premarket Exempt : No

Product Code : NZW

Prescription Use : Yes

Device Count : 60

Medefil Heparin Lock Flush Syringe, 1 Unit/mL - 30364253444235 Catalog Number : MIH-4423

Device Description : Medefil Heparin Lock Flush Syringe, 1 Unit/mL, 3mL in 6mL Syringe, Does not cont Medefil Heparin Lock Flush Syringe, 1 Unit/mL, 3mL in 6mL Syringe, Does not contain natural rubber latex or preservatives. Contents and its pathway are sterile. Single use.

Device Class :

Duns Number: 016448669

Premarket Exempt : No

Product Code : NZW

Prescription Use : Yes

Device Count : 60

Heparin Lock Flush Syringe 1 Units /mL - 30364253444259 Catalog Number : MIH-4425

Device Description : Medefil 1 Units/mL Heparin IV Flush Syringe, 5mL fill in 6mL syringe, Does not c Medefil 1 Units/mL Heparin IV Flush Syringe, 5mL fill in 6mL syringe, Does not contain natural rubber latex or preservatives, Contents and its pathway are sterile, Single Use

Device Class :

Duns Number: 016448669

Premarket Exempt : No

Product Code : NZW

Prescription Use : Yes

Device Count : 60

Medefil Heparin Lock Flush Syringe, 1 Unit/mL - 30364253444303 Catalog Number : MIH-4430

Device Description : Medefil Heparin Lock Flush Syringe, 1 Unit/mL, 10mL in 12mL Syringe, Does not co Medefil Heparin Lock Flush Syringe, 1 Unit/mL, 10mL in 12mL Syringe, Does not contain natural rubber latex or preservatives. Contents and its pathway are sterile. Single use.

Device Class :

Duns Number: 016448669

Premarket Exempt : No

Product Code : NZW

Prescription Use : Yes

Device Count : 60

Medefil Heparin Lock Flush Syringe, 1 Unit/mL - 30364253444334 Catalog Number : MIH-4433

Device Description : Medefil Heparin Lock Flush Syringe, 1 Unit/mL, 3mL in 12mL Syringe, Does not con Medefil Heparin Lock Flush Syringe, 1 Unit/mL, 3mL in 12mL Syringe, Does not contain natural rubber latex or preservatives. Contents and its pathway are sterile. Single use.

Device Class :

Duns Number: 016448669

Premarket Exempt : No

Product Code : NZW

Prescription Use : Yes

Device Count : 60

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