INFUSION SAFETY PRODUCTS, INC.

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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

Non-Coring (Huber) Needle (PTI) (10)

Premarket Exempt

Clear

Infusion Safety Products, Inc. - 00856673008009 Catalog Number :

Device Description : 19ga x .50" RA, Non-Coring Safety Huber Needle Infusion Set with 7.5" tubing, La 19ga x .50" RA, Non-Coring Safety Huber Needle Infusion Set with 7.5" tubing, Latex Free, Non-DEHP Tubing, Lipid Resistant, Rated to 300 psi, Approx. Priming Volume .25cc

Device Class : 2

Duns Number: 024502047

Premarket Exempt : No

Product Code : PTI

Prescription Use : Yes

Device Count : 1

Infusion Safety Products, Inc. - 00856673008016 Catalog Number :

Device Description : 19ga x .75" RA, Non-Coring Safety Huber Needle Infusion Set with 7.5" tubing, La 19ga x .75" RA, Non-Coring Safety Huber Needle Infusion Set with 7.5" tubing, Latex Free, Non-DEHP Tubing, Lipid Resistant, Rated to 300 psi, Approx. Priming Volume .25cc

Device Class : 2

Duns Number: 024502047

Premarket Exempt : No

Product Code : PTI

Prescription Use : Yes

Device Count : 1

Infusion Safety Products, Inc. - 00856673008023 Catalog Number :

Device Description : 19ga x 1.00" RA, Non-Coring Safety Huber Needle Infusion Set with 7.5" tubing, L 19ga x 1.00" RA, Non-Coring Safety Huber Needle Infusion Set with 7.5" tubing, Latex Free, Non-DEHP Tubing, Lipid Reisistant, Rated to 300 psi, Approx. Priming Volume .25cc

Device Class :

Duns Number: 024502047

Premarket Exempt : No

Product Code : PTI

Prescription Use : Yes

Device Count : 1

Infusion Safety Products, Inc. - 00856673008030 Catalog Number :

Device Description : 19ga x 1.50" RA, Non-Coring Safety Huber Needle Infusion Set with 7.5" tubing, L 19ga x 1.50" RA, Non-Coring Safety Huber Needle Infusion Set with 7.5" tubing, Latex Free, Non-DEHP Tubing, Lipid Resistant, Rated to 300 psi, Approx. Priming Volume .25cc

Device Class :

Duns Number: 024502047

Premarket Exempt : No

Product Code : PTI

Prescription Use : Yes

Device Count : 1

Infusion Safety Products, Inc. - 00856673008047 Catalog Number :

Device Description : 20ga x .50" RA, Non-Coring Safety Huber Needle Infusion Set with 7.5" tubing, La 20ga x .50" RA, Non-Coring Safety Huber Needle Infusion Set with 7.5" tubing, Latex Free, Non-DEHP Tubing, Lipid Resistant, Rated to 300 psi, Approx. Priming Volume .25cc

Device Class :

Duns Number: 024502047

Premarket Exempt : No

Product Code : PTI

Prescription Use : Yes

Device Count : 1

Infusion Safety Products, Inc. - 00856673008054 Catalog Number :

Device Description : 20ga x .75" RA, Non-Coring Safety Huber Needle Infusion Set with 7.5" tubing, La 20ga x .75" RA, Non-Coring Safety Huber Needle Infusion Set with 7.5" tubing, Latex Free, Non-DEHP Tubing, Lipid Resistant, Rated to 300 psi, Approx. Priming Volume .25cc

Device Class :

Duns Number: 024502047

Premarket Exempt : No

Product Code : PTI

Prescription Use : Yes

Device Count : 1

Infusion Safety Products, Inc. - 00856673008061 Catalog Number :

Device Description : 20ga x 1.00" RA, Non-Coring Safety Huber Needle Infusion Set with 7.5" tubing, L 20ga x 1.00" RA, Non-Coring Safety Huber Needle Infusion Set with 7.5" tubing, Latex Free, Non-DEHP Tubing, Lipid Resistant, Rated to 300 psi, Approx. Priming Volume .25cc

Device Class :

Duns Number: 024502047

Premarket Exempt : No

Product Code : PTI

Prescription Use : Yes

Device Count : 1

Infusion Safety Products, Inc. - 00856673008078 Catalog Number :

Device Description : 20ga x 1.50" RA, Non-Coring Safety Huber Needle Infusion Set with 7.5" tubing, L 20ga x 1.50" RA, Non-Coring Safety Huber Needle Infusion Set with 7.5" tubing, Latex Free, Non-DEHP Tubing, Lipid Resistant, Rated to 300 psi, Approx. Priming Volume .25cc

Device Class : 2

Duns Number: 024502047

Premarket Exempt : No

Product Code : PTI

Prescription Use : Yes

Device Count : 1

Infusion Safety Products, Inc. - 00856673008085 Catalog Number :

Device Description : 22ga x .50" RA, Non-Coring Safety Huber Needle Infusion Set with 7.5" tubing, La 22ga x .50" RA, Non-Coring Safety Huber Needle Infusion Set with 7.5" tubing, Latex Free, Non-DEHP Tubing, Lipid Resistant, Rated to 300 psi, Approx. Priming Volume .25cc

Device Class :

Duns Number: 024502047

Premarket Exempt : No

Product Code : PTI

Prescription Use : Yes

Device Count : 1

Infusion Safety Products, Inc. - 00856673008092 Catalog Number :

Device Description : 22ga x .75" RA, Non-Coring Safety Huber Needle Infusion Set with 7.5" tubing, La 22ga x .75" RA, Non-Coring Safety Huber Needle Infusion Set with 7.5" tubing, Latex Free, Non-DEHP Tubing, Rated to 300 psi, Approx. Priming Volume .25cc

Device Class :

Duns Number: 024502047

Premarket Exempt : No

Product Code : PTI

Prescription Use : Yes

Device Count : 1

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