FDA.reportPublic FDA data

Infusion Safety Products, Inc.

Primary DI
10856673008013
Brand
Infusion Safety Products, Inc.
Company
INFUSION SAFETY PRODUCTS, INC.
Model
ISP1975
Device description
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
Published
2020-02-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PTINon-Coring (Huber) Needle

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PTINon-Coring (Huber) NeedleGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170881000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170881000ISP Safety Huber Needle Infusion SetInfusion Safety Products, Inc.2017-12-14PTI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10856673008013PackageGS125In Commercial Distribution
00856673008016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085667300801310856673008013
00856673008016008566730080168566730080160856673008016

GMDN Terms#

Term, Definition table
TermDefinition
Vascular port administration setA collection of devices designed to conduct fluids from an intravenous (IV) fluid container to a patient's venous system via a previously implanted injection/infusion port. It typically includes a noncoring needle designed with a lateral hole (side-hole), tubing, connectors, chambers, clamps and may include an injection placement aid. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
603-357-0536customerservice@infusionsafetyproducts.com

Regulatory Flags#

DUNS number
024502047
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856673008009Infusion Safety Products, Inc.ISP1952020-02-25
00856673008016Infusion Safety Products, Inc.ISP19752020-02-25
10856673008006Infusion Safety Products, Inc.ISP1952020-02-25
08566730080016Infusion Safety Products, Inc.ISP1952018-07-20
08566730080023Infusion Safety Products, Inc.ISP19752018-07-20
00856673008023Infusion Safety Products, Inc.ISP1912018-07-20
00856673008030Infusion Safety Products, Inc.ISP19152018-07-20
00856673008047Infusion Safety Products, Inc.ISP2052018-07-20
00856673008054Infusion Safety Products, Inc.ISP20752018-07-20
00856673008061Infusion Safety Products, Inc.ISP2012018-07-20
00856673008078Infusion Safety Products, Inc.ISP20152018-07-20
00856673008085Infusion Safety Products, Inc.ISP2252018-07-20
00856673008092Infusion Safety Products, Inc.ISP22752018-07-20
00856673008108Infusion Safety Products, Inc.ISP2212018-07-20
00856673008115Infusion Safety Products, Inc.ISP22152018-07-20
00856673008122Infusion Safety Products, Inc.ISP195Y2018-07-20
00856673008139Infusion Safety Products, Inc.ISP1975Y2018-07-20
00856673008146Infusion Safety Products, Inc.ISP191Y2018-07-20
00856673008153Infusion Safety Products, Inc.ISP1915Y2018-07-20
00856673008160Infusion Safety Products, Inc.ISP205Y2018-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04987488111298K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingSB-KAWASUMI LABORATORIES, INC.PTI2026-05-31
04987488111304K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingSB-KAWASUMI LABORATORIES, INC.PTI2026-05-31
04987488111311K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingSB-KAWASUMI LABORATORIES, INC.PTI2026-05-31
04987488111328K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingSB-KAWASUMI LABORATORIES, INC.PTI2026-05-31
04987488111335K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingSB-KAWASUMI LABORATORIES, INC.PTI2026-05-31
04987488111342K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingSB-KAWASUMI LABORATORIES, INC.PTI2026-05-31
04987488111359K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingSB-KAWASUMI LABORATORIES, INC.PTI2026-05-31
04987488111366K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingSB-KAWASUMI LABORATORIES, INC.PTI2026-05-31
04987488111373K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingSB-KAWASUMI LABORATORIES, INC.PTI2026-05-31
04987488111380K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingSB-KAWASUMI LABORATORIES, INC.PTI2026-05-31
04987488111397K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingSB-KAWASUMI LABORATORIES, INC.PTI2026-05-31
04987488111403K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingSB-KAWASUMI LABORATORIES, INC.PTI2026-05-31
00801741239403SafeStepBard Access Systems, Inc.PTI2026-04-07
00801741235238PowerLoc MaxBard Access Systems, Inc.PTI2025-04-10
00801741235245PowerLoc MaxBard Access Systems, Inc.PTI2025-04-10
00801741235252PowerLoc MaxBard Access Systems, Inc.PTI2025-04-10
00801741235269Safe StepBard Access Systems, Inc.PTI2025-04-10
00801741235283Safe StepBard Access Systems, Inc.PTI2025-04-10
10801741235235PowerLoc MaxBard Access Systems, Inc.PTI2025-04-10
10801741235242PowerLoc MaxBard Access Systems, Inc.PTI2025-04-10
20801741235256PowerLoc MaxBard Access Systems, Inc.PTI2025-04-10
10801741235266Safe StepBard Access Systems, Inc.PTI2025-04-10
10801741235280Safe StepBard Access Systems, Inc.PTI2025-04-10
00801741232350AllPoints Port Access System PowerLoc MaxBard Access Systems, Inc.PTI2024-12-05
00801741232367AllPoints Port Access System PowerLoc MaxBard Access Systems, Inc.PTI2024-12-05
00801741232374AllPoints Port Access System PowerLoc MaxBard Access Systems, Inc.PTI2024-12-05
00801741232398AllPoints Port Access System PowerLoc MaxBard Access Systems, Inc.PTI2024-12-05
00801741232473AllPoints Port Access System SafeStepBard Access Systems, Inc.PTI2024-12-05
00801741232480AllPoints Port Access System SafeStepBard Access Systems, Inc.PTI2024-12-05
00801741232497AllPoints Port Access System SafeStepBard Access Systems, Inc.PTI2024-12-05