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

Saline, Vascular Access Flush (NGT) (8) Heparin, Vascular Access Flush (NZW) (2)

Premarket Exempt

Clear

Normnal Saline I.V. Flush Syringe - 30364253111212 Catalog Number : MIS-1121

Device Description : Medefil Normal Saline IV Flush Syringe, 1mL in 6mL syringe, does not contain nat Medefil Normal Saline IV Flush Syringe, 1mL in 6mL syringe, does not contain natural latex rubber or preservatives, contents and its pathway are sterile. Single Use.

Device Class :

Duns Number: 016448669

Premarket Exempt : No

Product Code : NGT

Prescription Use : Yes

Device Count : 60

Normal Saline IV Flush Syringe - 30364253111229 Catalog Number : MIS-1122

Device Description : Medefil Normal Saline IV Flush Syringe, 2mL in 6mL Syringe, Does not contain nat Medefil Normal Saline IV Flush Syringe, 2mL 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 : NGT

Prescription Use : Yes

Device Count : 60

Normal Saline IV Flush Syringe - 30364253111236 Catalog Number : MIS-1123

Device Description : Medefil Normal Saline IV Flush Syringe, 3mL fill in 6mL syringe, Does not contai Medefil Normal Saline IV Flush Syringe, 3mL 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 : NGT

Prescription Use : Yes

Device Count : 60

Normal Saline IV Flush Syringe - 30364253111250 Catalog Number : MIS-1125

Device Description : Medefil Normal Saline IV Flush Syringe, 5mL fill in 6mL syringe, Does not contai Medefil Normal Saline 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 : NGT

Prescription Use : Yes

Device Count : 60

Normal Saline IV Flush Syringe - 30364253111304 Catalog Number : MIS-1130

Device Description : Medefil Normal Saline IV Flush Syringe, 10mL fill in 12mL syringe, Does not cont Medefil Normal Saline IV Flush Syringe, 10mL fill 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 : NGT

Prescription Use : Yes

Device Count : 60

Normal Saline IV Flush Syringe - 30364253111335 Catalog Number : MIS-1133

Device Description : Medefil Normal Saline IV Flush Syringe, 3mL fill in 12mL syringe, Does not conta Medefil Normal Saline IV Flush Syringe, 3mL fill 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 : NGT

Prescription Use : Yes

Device Count : 60

Normal Saline IV Flush Syringe - 30364253111359 Catalog Number : MIS-1135

Device Description : Medefil Normal Saline IV Flush Syringe, 5mL fill in 12mL syringe, Does not conta Medefil Normal Saline IV Flush Syringe, 5mL fill 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 : NGT

Prescription Use : Yes

Device Count : 60

Normal Saline IV Flush Syriinge - 30364253111526 Catalog Number : MIS-1152

Device Description : Medefil Normal Saline IV Flush Syringe , 2.5mL fill 6mL Syringe, Does not contai Medefil Normal Saline IV Flush Syringe , 2.5mL fill 6mL Syringe, Does not contain natural rubber latex, Contents and its pathway are sterile, Single Use

Device Class :

Duns Number: 016448669

Premarket Exempt : No

Product Code : NGT

Prescription Use : Yes

Device Count : 60

Heparin Lock Flush Syringe 10 Units/mL - 30364253222215 Catalog Number : MIH-2221

Device Description : Medefil 10 Units/mL Heparin Lock Flush Syringe, 1 mL fill in 6 mL syringe, Does Medefil 10 Units/mL Heparin Lock Flush Syringe, 1 mL fill in 6 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 Heparin Lock Flush Syringe, 10 Unit/mL - 30364253222222 Catalog Number : MIH-2222

Device Description : Medefil Heparin Lock Flush Syringe, 10 Unit/mL, 2mL in 6mL Syringe, Does not con Medefil Heparin Lock Flush Syringe, 10 Unit/mL, 2mL 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

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