FDA.reportPublic FDA data

ProFusion Therapeutic Infusion Needle

Primary DI
00827002584747
Brand
ProFusion Therapeutic Infusion Needle
Company
COOK BIODEVICE LLC
Model
PTIN-21-20.0
Catalog number
G58474
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
OTC
false
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
00827002584747PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002584747008270025847478270025847470827002584747

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
Length20Centimeter
Needle Gauge21Gauge

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
DM exempt
false
Premarket exempt
true
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
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
00827002475809ProFusion Therapeutic Infusion NeedlePTIN-25-7.5G475802021-03-04
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