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. - 00856673008108 Catalog Number :

Device Description : 22ga x 1.00" RA, Non-Coring Safety Huber Needle Infusion Set with 7.5" tubing, L 22ga x 1.00" 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 : 2

Duns Number: 024502047

Premarket Exempt : No

Product Code : PTI

Prescription Use : Yes

Device Count : 1

Infusion Safety Products, Inc. - 00856673008115 Catalog Number :

Device Description : 22ga x 1.50" RA, Non-Coring Safety Huber Needle Infusion Set with 7.5" tubing, L 22ga 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. - 00856673008122 Catalog Number :

Device Description : 19ga x .50" RA, Non-Coring Safety Huber Needle Infusion Set with 8.5" tubing and 19ga x .50" RA, Non-Coring Safety Huber Needle Infusion Set with 8.5" tubing and a "Y" port with a non-vented cap, Latex Free, Non-DEHP Tubing, Lipid Resistant, Rated to 300 psi, Approx. Priming Volume .35cc

Device Class :

Duns Number: 024502047

Premarket Exempt : No

Product Code : PTI

Prescription Use : Yes

Device Count : 1

Infusion Safety Products, Inc. - 00856673008139 Catalog Number :

Device Description : 19ga x .75" RA, Non-Coring Safety Huber Needle Infusion Set with 8.5" tubing and 19ga x .75" RA, Non-Coring Safety Huber Needle Infusion Set with 8.5" tubing and a "Y" port with a non-vented cap, Latex Free, Non-DEHP Tubing, Lipid Resistant, Rated to 300 psi, Approx. Priming Volume .35cc

Device Class :

Duns Number: 024502047

Premarket Exempt : No

Product Code : PTI

Prescription Use : Yes

Device Count : 1

Infusion Safety Products, Inc. - 00856673008146 Catalog Number :

Device Description : 19ga x 1.00" RA, Non-Coring Safety Huber Needle Infusion Set with 8.5" tubing an 19ga x 1.00" RA, Non-Coring Safety Huber Needle Infusion Set with 8.5" tubing and a "Y" port with a non-vented cap, Latex Free, Non-DEHP Tubing, Lipid Resistant, Rated to 300 psi, Approx. Priming Volume .35cc

Device Class :

Duns Number: 024502047

Premarket Exempt : No

Product Code : PTI

Prescription Use : Yes

Device Count : 1

Infusion Safety Products, Inc. - 00856673008153 Catalog Number :

Device Description : 19ga x 1.50" RA, Non-Coring Safety Huber Needle Infusion Set with 8.5" tubing an 19ga x 1.50" RA, Non-Coring Safety Huber Needle Infusion Set with 8.5" tubing and a "Y" port with a non-vented cap, Latex Free, Non-DEHP Tubing, Lipid Resistant, Rated to 300 psi, Approx. Priming Volume .35cc

Device Class :

Duns Number: 024502047

Premarket Exempt : No

Product Code : PTI

Prescription Use : Yes

Device Count : 1

Infusion Safety Products, Inc. - 00856673008160 Catalog Number :

Device Description : 20ga x .50" RA, Non-Coring Safety Huber Needle Infusion Set with 8.5" tubing and 20ga x .50" RA, Non-Coring Safety Huber Needle Infusion Set with 8.5" tubing and a "Y" port with a non-vented cap, Latex Free, Non-DEHP Tubing, Lipid Resistant, Rated to 300 psi, Approx. Priming Volume .35cc

Device Class :

Duns Number: 024502047

Premarket Exempt : No

Product Code : PTI

Prescription Use : Yes

Device Count : 1

Infusion Safety Products, Inc. - 00856673008177 Catalog Number :

Device Description : 20ga x .75" RA, Non-Coring Safety Huber Needle Infusion Set with 8.5" tubing and 20ga x .75" RA, Non-Coring Safety Huber Needle Infusion Set with 8.5" tubing and a "Y" port with a non-vented cap, Latex Free, Non-DEHP Tubing, Lipid Resistant, Rated to 300 psi, Approx. Priming Volume .35cc

Device Class :

Duns Number: 024502047

Premarket Exempt : No

Product Code : PTI

Prescription Use : Yes

Device Count : 1

Infusion Safety Products, Inc. - 00856673008184 Catalog Number :

Device Description : 20ga x 1.00" RA, Non-Coring Safety Huber Needle Infusion Set with 8.5" tubing an 20ga x 1.00" RA, Non-Coring Safety Huber Needle Infusion Set with 8.5" tubing and a "Y" port with a non-vented cap, Latex Free, Non-DEHP Tubing, Lipid Resistant, Rated to 300 psi, Approx. Priming Volume .35cc

Device Class :

Duns Number: 024502047

Premarket Exempt : No

Product Code : PTI

Prescription Use : Yes

Device Count : 1

Infusion Safety Products, Inc. - 00856673008191 Catalog Number :

Device Description : 20ga x 1.50" RA, Non-Coring Safety Huber Needle Infusion Set with 8.5" tubing an 20ga x 1.50" RA, Non-Coring Safety Huber Needle Infusion Set with 8.5" tubing and a "Y" port with a non-vented cap, Latex Free, Non-DEHP Tubing, Lipid Resistant, Rated to 300 psi, Approx. Priming Volume .35cc

Device Class :

Duns Number: 024502047

Premarket Exempt : No

Product Code : PTI

Prescription Use : Yes

Device Count : 1

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