FDA.reportPublic FDA data

Suction tip

Primary DI
38033178018709
Brand
Suction tip
Company
SORIN GROUP ITALIA SRL
Model
SU-20601
Published
2024-04-04
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

Product Codes#

Code, Name table
CodeName
DTSSucker, cardiotomy return, cardiopulmonary bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTSSucker, Cardiotomy Return, Cardiopulmonary BypassCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
38033178018709PackageGS110In Commercial Distribution
08033178018708PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3803317801870938033178018709
08033178018708080331780187088033178018708

GMDN Terms#

Term, Definition table
TermDefinition
Suction system catheter, general-purposeA sterile flexible tube used in the removal of fluids from the body via a natural body orifice, surgical incision, or wound. It is typically designed to be attached to a collection canister or bottle where a vacuum is created by a suction system via an intermediate tubing. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
442126587
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
08033178102933DHF02 HEMOCONCENTRATOR2015-07-15
08033178102940DHF06 HEMOCONCENTRATOR2015-07-15
08033178109062CSC 14CSC14 + PURGE LINE2015-07-10
08033178112253INSPIRE6M2015-05-13
08033178112277INSPIRE6F M2015-05-13
08033178112284INSPIRE8F M2015-05-13
08033178112291INSPIREHVR2015-05-13
08033178112307INSPIREHVR DUAL2015-05-13
08033178112352INSPIRE6 PH.I.S.I.O.2015-05-13
08033178112369INSPIRE8 PH.I.S.I.O.2015-05-13
08033178112376INSPIRE6F PH.I.S.I.O.2015-05-13
08033178112383INSPIRE8F PH.I.S.I.O.2015-05-13
08033178112390INSPIRE6 DUAL PH.I.S.I.O.2015-05-13
08033178112406INSPIRE8 DUAL PH.I.S.I.O.2015-05-13
08033178112413INSPIRE6F DUAL PH.I.S.I.O.2015-05-13
08033178112420INSPIRE8F DUAL PH.I.S.I.O.2015-05-13
08033178113014INSPIRESVR 12002017-03-29
08033178113182INSPIRE7 M2019-08-28
08033178113212INSPIRE72019-08-28
08033178113236INSPIRE7 DUAL2019-08-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841742149356HNM MedicalHNM STAINLESS, LLC.DTS2025-01-27
10841742149353HNM MedicalHNM STAINLESS, LLC.DTS2025-01-27
08033178018647Suction tipSORIN GROUP ITALIA SRLDTS2024-04-04
08033178018654Suction tipSORIN GROUP ITALIA SRLDTS2024-04-04
08033178018661Suction tipSORIN GROUP ITALIA SRLDTS2024-04-04
08033178018678Suction tipSORIN GROUP ITALIA SRLDTS2024-04-04
08033178018708Suction tipSORIN GROUP ITALIA SRLDTS2024-04-04
08033178018715Suction tipSORIN GROUP ITALIA SRLDTS2024-04-04
08033178018722Suction tipSORIN GROUP ITALIA SRLDTS2024-04-04
08033178018739Suction tipSORIN GROUP ITALIA SRLDTS2024-04-04
08033178018746Suction tipSORIN GROUP ITALIA SRLDTS2024-04-04
38033178018648Suction tipSORIN GROUP ITALIA SRLDTS2024-04-04
38033178018655Suction tipSORIN GROUP ITALIA SRLDTS2024-04-04
38033178018662Suction tipSORIN GROUP ITALIA SRLDTS2024-04-04
38033178018679Suction tipSORIN GROUP ITALIA SRLDTS2024-04-04
38033178018716Suction tipSORIN GROUP ITALIA SRLDTS2024-04-04
38033178018723Suction tipSORIN GROUP ITALIA SRLDTS2024-04-04
38033178018730Suction tipSORIN GROUP ITALIA SRLDTS2024-04-04
38033178018747Suction tipSORIN GROUP ITALIA SRLDTS2024-04-04
08033178018753Suction tipSORIN GROUP ITALIA SRLDTS2024-03-20
38033178018754Suction tipSORIN GROUP ITALIA SRLDTS2024-03-20
00842962106426HNM MedicalHNM STAINLESS, LLC.DTS2024-02-09
05060660971510TEMEDTemedDTS2023-06-14
05060660971503TEMEDTemedDTS2023-06-14
05060660971749TEMEDTemedDTS2023-06-14
00818354013955ClearView MV Atrial DepressorATRICURE, INC.DTS2016-10-24
00818354013962ClearView MV Atrial DepressorATRICURE, INC.DTS2016-10-24
B0662010350000ADULT GROOVED TIP SUCKERNOVOSCI CORP.DTS2016-09-26
B0662010360000Pediatric Grooved Tip SuckerNOVOSCI CORP.DTS2016-09-26
B0662010370000INFANT GROOVED TIP SUCKERNOVOSCI CORP.DTS2016-09-26