FDA.reportPublic FDA data

DLP®

Primary DI
20613994570448
Brand
DLP®
Company
MEDTRONIC, INC.
Model
10060
Device description
SUCTION 10060 INTRACAR 20FR TIP 20PK 17L
Published
2016-05-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DTSSUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K791846000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K791846000DISPOSSABLE SUCTION TUBE, 6 FRENCHDlp, Inc.1979-10-02DTS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20613994570448PrimaryGS10
00613994570444Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061399457044820613994570448
00613994570444006139945704446139945704440613994570444

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
Device count
20
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000443214NA2ACHC2024-05-18
00763000368470Aurora EV-ICD™ MRI SureScan™DVEA3E42023-11-02
00763000001513Primo MRI™ DR SureScan™DDMD3D42018-06-02
00763000001551Primo MRI™ VR SureScan™DVMD3D42018-06-02
00763000059491Evera MRI™ XT DR SureScan®DDMB1D42017-10-20
00763000059651Viva™ Quad XT CRT-DDTBA1QQ2017-10-21
00763000059668Viva™ XT CRT-DDTBA1D42017-10-21
00763000059705Evera MRI™ S DR SureScan®DDMC3D42017-10-21
00643169314092Evera MRI™ XT DR SureScan®DDMB1D42015-09-21
00643169314153Evera MRI™ XT VR SureScan®DVMB1D42015-09-21
00643169720497Evera MRI™ XT DR SureScan®DDMB1D42017-09-15
00643169735637Percepta™ CRT-P MRI SureScan™W1TR012017-06-18
00643169735644Percepta™ Quad CRT-P MRI SureScan™W4TR012017-06-18
00643169735651Serena™ CRT-P MRI SureScan™W1TR022017-06-18
00643169735668Serena™ Quad CRT-P MRI SureScan™W4TR022017-06-18
00643169735675Solara™ CRT-P MRI SureScan™W1TR032017-06-18
00643169891401Percepta™ CRT-P MRI SureScan™W1TR012017-10-20
00643169891418Percepta™ Quad CRT-P MRI SureScan™W4TR012017-10-20
00643169891425Serena™ CRT-P MRI SureScan™W1TR022017-10-20
00643169891432Serena™ Quad CRT-P MRI SureScan™W4TR022017-10-20

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
38033178018709Suction 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