Infusion Safety Products, Inc.

Primary DI
28566730080096
Brand
Infusion Safety Products, Inc.
Company
INFUSION SAFETY PRODUCTS, INC.
Model
ISP225
Device description
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
Published
2018-07-20
Public version status
Update
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
28566730080096PackageGS125In Commercial Distribution
08566730080092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2856673008009628566730080096
08566730080092085667300800928566730080092

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
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
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

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