FDA.reportPublic FDA data

Single Use Professional

Primary DI
05055299103159
Brand
Single Use Professional
Company
EAKIN SURGICAL LIMITED
Model
S214
Catalog number
S214
Device description
Straight 6fg contains 50 units
Published
2016-08-19
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
GAANeedle, Aspiration And Injection, Disposable
GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAANeedle, Aspiration And Injection, DisposableGeneral, Plastic Surgery1
GCXApparatus, Suction, Operating-Room, Wall Vacuum PoweredGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055299103234PackageGS19In Commercial Distribution
05055299103159PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055299103234050552991032345055299103234
05055299103159050552991031595055299103159

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass cannula, arterialA sterile, semi-rigid or rigid tube intended to be used during open heart surgery where it is surgically inserted for perfusion of the ascending aorta, serving as a channel for the transport of pumped, oxygenated, blood from a cardiopulmonary bypass system (heart-lung machine) tubing circuit. It is typically a moulded plastic tube with stainless steel wire reinforcement, to prevent kinking/collapse, having multiple perforations or flutes at the distal end which help diffuse and disperse incoming blood. It may be inserted using a compatible trocar. Some types may be heparin coated and include a pressure monitoring port. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge6French

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+440292074740contactus@pelicanfh.co.uk
+440292074740QARA@eakinhealthcare.com

Regulatory Flags#

DUNS number
239505063
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055299101186Single Use Surgical ProfessionalS044S0442016-08-19
05055299106211Single Use Surgical ProfessionalS443S4432016-08-19
05055299100776Single Use Professional6fgN1006fgN1002016-08-09
05055299100783Single Use Professional9fgN1009fgN1002016-08-09
05055299100790Single Use Professional6fgN1406fgN1402016-08-09
05055299100806Single Use Professional9fgN1409fgN1402016-08-09
05055299100813Single Use Professional6fgF1406fgF1402016-08-09
05055299100820Single Use Professional9fgF1409fgF1402016-08-09
05055299100837Single Use ProfessionalS001S0012016-08-09
05055299100844Single Use ProfessionalS002S0022016-08-09
05055299100851Single Use ProfessionalS005S0052016-08-09
05055299100868Single Use ProfessionalS007S0072016-08-09
05055299100875Single Use ProfessionalS008S0082016-08-09
05055299100899Single Use ProfessionalS010S0102016-08-09
05055299100905Single Use ProfessionalS011S0112016-08-09
05055299100912Single Use ProfessionalS012S0122016-08-09
05055299100929Single Use ProfessionalS013S0132016-08-09
05055299100936Single Use ProfessionalS014S0142016-08-09
05055299100943Single Use ProfessionalS015S0152016-08-09
05055299100981Single Use ProfessionalS019S0192016-08-19

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10192253025125MonojectCardinal Health 200, LLCGAA2026-01-12
10192253043365CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
10192253043372CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
10192253043389CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
10192253043396CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
10192253043402CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
10192253043419CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
08682952420093DeRoyalPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIGCX2025-11-06
08800176593069WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-14
08800176593076WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-14
08800176593083WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-14
08800176592949WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592956WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592963WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592970WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592987WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592994WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592390WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592406WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592413WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592420WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592444WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592451WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592468WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592475WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592499WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592505WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08