Infusion Safety Products, Inc.

GUDID 28566730080195

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

INFUSION SAFETY PRODUCTS, INC.

Vascular port administration set
Primary Device ID28566730080195
NIH Device Record Key8651e136-7b7f-4c5d-8d0c-dba0ea23f68f
Commercial Distribution StatusIn Commercial Distribution
Brand NameInfusion Safety Products, Inc.
Version Model NumberISP201Y
Company DUNS024502047
Company NameINFUSION SAFETY PRODUCTS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone603-357-0536
Emailcustomerservice@infusionsafetyproducts.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108566730080191 [Primary]
GS128566730080195 [Package]
Contains: 08566730080191
Package: [25 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PTINon-Coring (Huber) Needle

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-10-23
Device Publish Date2018-07-20

On-Brand Devices [Infusion Safety Products, Inc.]

2856673008024922ga x 1.50" RA, Non-Coring Safety Huber Needle Infusion Set with 8.5" tubing and a "Y" port wit
2856673008023222ga x 1.00" RA, Non-Coring Safety Huber Needle Infusion Set with 8.5" tubing and a "Y" port wit
2856673008022522ga x .75" RA, Non-Coring Safety Huber Needle Infusion Set with 8.5" tubing and a "Y" port with
2856673008021822ga x .50" RA, Non-Coring Safety Huber Needle Infusion Set with 8.5" tubing and a "Y" port with
2856673008020120ga x 1.50" RA, Non-Coring Safety Huber Needle Infusion Set with 8.5" tubing and a "Y" port wit
2856673008019520ga x 1.00" RA, Non-Coring Safety Huber Needle Infusion Set with 8.5" tubing and a "Y" port wit
2856673008018820ga x .75" RA, Non-Coring Safety Huber Needle Infusion Set with 8.5" tubing and a "Y" port with
2856673008017120ga x .50" RA, Non-Coring Safety Huber Needle Infusion Set with 8.5" tubing and a "Y" port with
2856673008016419ga x 1.50" RA, Non-Coring Safety Huber Needle Infusion Set with 8.5" tubing and a "Y" port wit
2856673008015719ga x 1.00" RA, Non-Coring Safety Huber Needle Infusion Set with 8.5" tubing and a "Y" port wit
2856673008014019ga x .75" RA, Non-Coring Safety Huber Needle Infusion Set with 8.5" tubing and a "Y" port with
2856673008013319ga x .50" RA, Non-Coring Safety Huber Needle Infusion Set with 8.5" tubing and a "Y" port with
2856673008012622ga x 1.50" RA, Non-Coring Safety Huber Needle Infusion Set with 7.5" tubing, Latex Free, Non-D
2856673008011922ga x 1.00" RA, Non-Coring Safety Huber Needle Infusion Set with 7.5" tubing, Latex Free, Non-D
2856673008010222ga x .75" RA, Non-Coring Safety Huber Needle Infusion Set with 7.5" tubing, Latex Free, Non-DE
2856673008009622ga x .50" RA, Non-Coring Safety Huber Needle Infusion Set with 7.5" tubing, Latex Free, Non-DE
2856673008008920ga x 1.50" RA, Non-Coring Safety Huber Needle Infusion Set with 7.5" tubing, Latex Free, Non-D
2856673008007220ga x 1.00" RA, Non-Coring Safety Huber Needle Infusion Set with 7.5" tubing, Latex Free, Non-D
2856673008006520ga x .75" RA, Non-Coring Safety Huber Needle Infusion Set with 7.5" tubing, Latex Free, Non-DE
2856673008005820ga x .50" RA, Non-Coring Safety Huber Needle Infusion Set with 7.5" tubing, Latex Free, Non-DE
2856673008004119ga x 1.50" RA, Non-Coring Safety Huber Needle Infusion Set with 7.5" tubing, Latex Free, Non-D
2856673008003419ga x 1.00" RA, Non-Coring Safety Huber Needle Infusion Set with 7.5" tubing, Latex Free, Non-D
2856673008002719ga x .75" RA, Non-Coring Safety Huber Needle Infusion Set with 7.5" tubing, Latex Free, Non-DE
2856673008001019ga x .50" RA, Non-Coring Safety Huber Needle Infusion Set with 7.5" tubing, Latex Free, Non-DE
0085667300823822ga x 1.50" RA, Non-Coring Safety Huber Needle Infusion Set with 8.5" tubing and a "Y" port wit
0085667300822122ga x 1.00" RA, Non-Coring Safety Huber Needle Infusion Set with 8.5" tubing and a "Y" port wit
0085667300821422ga x .75" RA, Non-Coring Safety Huber Needle Infusion Set with 8.5" tubing and a "Y" port with
0085667300820722ga x .50" RA, Non-Coring Safety Huber Needle Infusion Set with 8.5" tubing and a "Y" port with
0085667300819120ga x 1.50" RA, Non-Coring Safety Huber Needle Infusion Set with 8.5" tubing and a "Y" port wit
0085667300818420ga x 1.00" RA, Non-Coring Safety Huber Needle Infusion Set with 8.5" tubing and a "Y" port wit
0085667300817720ga x .75" RA, Non-Coring Safety Huber Needle Infusion Set with 8.5" tubing and a "Y" port with
0085667300816020ga x .50" RA, Non-Coring Safety Huber Needle Infusion Set with 8.5" tubing and a "Y" port with
0085667300815319ga x 1.50" RA, Non-Coring Safety Huber Needle Infusion Set with 8.5" tubing and a "Y" port wit
0085667300814619ga x 1.00" RA, Non-Coring Safety Huber Needle Infusion Set with 8.5" tubing and a "Y" port wit
0085667300813919ga x .75" RA, Non-Coring Safety Huber Needle Infusion Set with 8.5" tubing and a "Y" port with
0085667300812219ga x .50" RA, Non-Coring Safety Huber Needle Infusion Set with 8.5" tubing and a "Y" port with
0085667300811522ga x 1.50" RA, Non-Coring Safety Huber Needle Infusion Set with 7.5" tubing, Latex Free, Non-D
0085667300810822ga x 1.00" RA, Non-Coring Safety Huber Needle Infusion Set with 7.5" tubing, Latex Free, Non-D
0085667300809222ga x .75" RA, Non-Coring Safety Huber Needle Infusion Set with 7.5" tubing, Latex Free, Non-DE
0085667300808522ga x .50" RA, Non-Coring Safety Huber Needle Infusion Set with 7.5" tubing, Latex Free, Non-DE
0085667300807820ga x 1.50" RA, Non-Coring Safety Huber Needle Infusion Set with 7.5" tubing, Latex Free, Non-D
0085667300806120ga x 1.00" RA, Non-Coring Safety Huber Needle Infusion Set with 7.5" tubing, Latex Free, Non-D
0085667300805420ga x .75" RA, Non-Coring Safety Huber Needle Infusion Set with 7.5" tubing, Latex Free, Non-DE
0085667300804720ga x .50" RA, Non-Coring Safety Huber Needle Infusion Set with 7.5" tubing, Latex Free, Non-DE
0085667300803019ga x 1.50" RA, Non-Coring Safety Huber Needle Infusion Set with 7.5" tubing, Latex Free, Non-D
0085667300802319ga x 1.00" RA, Non-Coring Safety Huber Needle Infusion Set with 7.5" tubing, Latex Free, Non-D
1085667300801319ga x .75" RA, Non-Coring Safety Huber Needle Infusion Set with 7.5" tubing, Latex Free, Non-DE
1085667300800619ga x .50" RA, Non-Coring Safety Huber Needle Infusion Set with 7.5" tubing, Latex Free, Non-DE
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