FDA.reportPublic FDA data

Infusion Safety Products, Inc.

Primary DI
00856673008115
Brand
Infusion Safety Products, Inc.
Company
INFUSION SAFETY PRODUCTS, INC.
Model
ISP2215
Device description
"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"
Published
2018-07-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
10856673008112PackageGS125In Commercial Distribution
00856673008115PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085667300811210856673008112
00856673008115008566730081158566730081150856673008115

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
Lot or batch
true
Expiration date on label
true

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
10856673008013Infusion Safety Products, Inc.ISP19752020-02-25
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
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