FDA.reportPublic FDA data

AESCULAP

Primary DI
04038653419470
Brand
AESCULAP
Company
Aesculap AG
Model
FB155R
Catalog number
FB155R
Device description
"SCHMID Vessel Irrigation Cannula, 6"", (150 mm), diam. 5 mm, malleable, luer lock, non-sterile, reusable"
Published
2020-06-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEACANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEACannula, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653419470PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653419470040386534194704038653419470

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags#

DUNS number
315018218
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04038653033997AESCULAPDC230RDC230R2020-06-17
04038653034321AESCULAPDE112RDE112R2020-06-17
04038653034369AESCULAPDE116RDE116R2020-06-17
04038653034376AESCULAPDE117RDE117R2020-06-17
04038653034406AESCULAPDE120RDE120R2020-06-17
04038653034901AESCULAPDE676RDE676R2020-06-17
04046963116194S4 CERVICALFW028UFW028U2020-08-24
04046963794248ELAN 4GA768GA7682020-04-24
04046963935184HI-LINE XXSGE813SUGE813SU2020-04-24
04046963935191HI-LINE XXSGE814SUGE814SU2020-04-24
04046963966362ELAN 4GA767GA7672020-04-24
04046964054907ELAN 4GA715RGA715R2020-04-24
04046964076664AESCULAPGE812SUGE812SU2020-04-24
04046964526213ECCOSGB068RGB068R2020-04-24
04038653013845AESCULAPOP297ROP297R2017-07-31
04038653081141AESCULAPOP913OP9132016-09-23
04038653081158AESCULAPOP914OP9142020-08-10
04038653013852AESCULAPOP298ROP298R2020-04-17
04046963730109AESCULAPOP923OP9232019-04-30
04046955273508AICONJJ612JJ6122022-02-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G453332414200PEAK MEDICALPeak Medical Distribution Inc.GEA2026-05-08
G589DS22G501DermaSculptCosmoFranceGEA2026-04-13
G589DS22G701DermaSculptCosmoFranceGEA2026-04-13
G589DS23G301DermaSculptCosmoFranceGEA2026-04-13
G589DS23G401DermaSculptCosmoFranceGEA2026-04-13
G589DS23G501DermaSculptCosmoFranceGEA2026-04-13
G589DS25G401DermaSculptCosmoFranceGEA2026-04-13
G589DS25G501DermaSculptCosmoFranceGEA2026-04-13
G589DS27G251DermaSculptCosmoFranceGEA2026-04-13
G589DS27G401DermaSculptCosmoFranceGEA2026-04-13
G589DS27G501DermaSculptCosmoFranceGEA2026-04-13
G589DS30G251DermaSculptCosmoFranceGEA2026-04-13
10192253037906MonojectCardinal Health 200, LLCGEA2026-04-07
10192253037913MonojectCardinal Health 200, LLCGEA2025-10-10
10669808004008SoftFil® EasyGuideProllenium MedicalGEA2025-08-28
10669808004084SoftFil® PrecisionProllenium MedicalGEA2025-08-28
10192253003444ArgyleCardinal Health 200, LLCGEA2024-10-09
10192253003451ArgyleCardinal Health 200, LLCGEA2024-10-09
10850013527028DannikDannik LLCGEA2023-01-21
10850013527073DannikDannik LLCGEA2023-01-21
10850013527080DannikDannik LLCGEA2023-01-21
10850013527097DannikDannik LLCGEA2023-01-21
10850013527103DannikDannik LLCGEA2023-01-21
10850013527110DannikDannik LLCGEA2023-01-21
10850013527127DannikDannik LLCGEA2023-01-21
10850013527134DannikDannik LLCGEA2023-01-21
10850013527141DannikDannik LLCGEA2023-01-21
10850013527158DannikDannik LLCGEA2023-01-21
10850013527165DannikDannik LLCGEA2023-01-21
10850013527172DannikDannik LLCGEA2023-01-21