FDA.reportPublic FDA data

ProFusion Therapeutic Infusion Needle

Primary DI
00827002475809
Brand
ProFusion Therapeutic Infusion Needle
Company
COOK BIODEVICE LLC
Model
PTIN-25-7.5
Catalog number
G47580
Device description
The ProFusion Needle is a stainless-steel needle with a trocar tip and distal sideports for infusion. The device also consists of a proximal plastic hub for Luer lock connections.
Published
2021-03-04
Public version status
New
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
GAANeedle, Aspiration And Injection, Disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAANeedle, Aspiration And Injection, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002475809PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002475809008270024758098270024758090827002475809

GMDN Terms#

Term, Definition table
TermDefinition
Subcutaneous infusion/injection port needleA sterile, sharp bevel-edged, hollow tubular metal instrument intended to be attached to a syringe and designed for the therapeutic injection or infusion of medicinal substances directly beneath the skin layer. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length7.5Centimeter
Needle Gauge25Gauge

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1.800.265.0945Customer-Service@CookRegentec.com

Regulatory Flags#

DUNS number
080411091
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00827002475700ProFusion Therapeutic Infusion NeedlePTIN-19-5.0G475702021-03-04
00827002475717ProFusion Therapeutic Infusion NeedlePTIN-19-7.5G475712021-03-04
00827002475724ProFusion Therapeutic Infusion NeedlePTIN-19-10.0G47572 2021-03-04
00827002475731ProFusion Therapeutic Infusion NeedlePTIN-19-15.0G47573 2021-03-04
00827002475748ProFusion Therapeutic Infusion NeedlePTIN-21-5.0G475742021-03-04
00827002475755ProFusion Therapeutic Infusion NeedlePTIN-21-7.5G475752021-03-04
00827002475762ProFusion Therapeutic Infusion NeedlePTIN-21-10.0G475762021-03-04
00827002475779ProFusion Therapeutic Infusion NeedlePTIN-21-15.0G475772021-03-04
00827002475786ProFusion Therapeutic Infusion NeedlePTIN-25-2.5G475782021-03-04
00827002475793ProFusion Therapeutic Infusion NeedlePTIN-25-5.0G475792021-03-04
00827002584747ProFusion Therapeutic Infusion NeedlePTIN-21-20.0G584742021-03-04
00827002584754ProFusion Therapeutic Infusion NeedlePTIN-21-25.0G584752021-03-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50192253036877MonojectCardinal Health 200, LLCGAA2026-03-23
30192253036880MonojectCardinal Health 200, LLCGAA2026-03-23
30192253036897MonojectCardinal Health 200, LLCGAA2026-03-23
50192253036907MonojectCardinal Health 200, LLCGAA2026-03-23
30192253036934MonojectCardinal Health 200, LLCGAA2026-03-23
30192253036941MonojectCardinal Health 200, LLCGAA2026-03-23
50192253036952MonojectCardinal Health 200, LLCGAA2026-03-23
50198956355451CARDINAL HEALTHCardinal Health 200, LLCGAA2026-03-19
MHC18018250EasyTouchMHC MEDICAL PRODUCTS, LLCGAA2026-03-17
00810235030860US Accessory KitMERZ NORTH AMERICA, INC.GAA2026-03-05
00810235030877US Rigid Needle with Support Cannula- Double BevelMERZ NORTH AMERICA, INC.GAA2026-03-05
00810235030884US Rigid Injection Needle with Huber PointMERZ NORTH AMERICA, INC.GAA2026-03-05
20850083784403Comfort EZS.D.I. USA, INC.GAA2026-02-13
50192253036860MonojectCardinal Health 200, LLCGAA2026-02-10
50192253036976MonojectCardinal Health 200, LLCGAA2026-02-10
50192253025260MonojectCardinal Health 200, LLCGAA2026-01-16
50198956310047CARDINAL HEALTHCardinal Health 200, LLCGAA2025-12-26
50198956290554CARDINAL HEALTHCardinal Health 200, LLCGAA2025-12-17
50198956168808CARDINAL HEALTHCardinal Health 200, LLCGAA2025-12-11
04046964941245Filter Straw®B. BRAUN MEDICAL INC.GAA2025-12-09
06938695502155Bone DrillShanghai Kinetic Medical Co., Ltd.GAA2025-12-09
06938695527004Bone DrillShanghai Kinetic Medical Co., Ltd.GAA2025-12-09
04046964943232NAB. BRAUN MEDICAL INC.GAA2025-12-02
04046964941221Filter Straw®B. BRAUN MEDICAL INC.GAA2025-12-02
50198956273182CARDINAL HEALTHCardinal Health 200, LLCGAA2025-11-14
04250676736109VoiceInject injection needleSpiggle & Theis Medizintechnik GmbHGAA2025-09-09
08800176592673WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592680WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592697WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592703WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08