FDA.reportPublic FDA data

Suction tip

Primary DI
10803622105835
Brand
Suction tip
Company
LIVANOVA USA, INC.
Model
SU-xxxxx
Published
2015-07-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K982891000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K982891000CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDSCalifornia Medical Laboratories, Inc.1998-09-30DTS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10803622105835PackageGS110In Commercial Distribution
00803622105838PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080362210583510803622105835
00803622105838008036221058388036221058380803622105838

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080914995
Device count
1
DM exempt
false
Premarket exempt
false
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
00803622146947Vascular Dilator Kit200-1202020-08-19
00803622112522Vascular Dilator Kit200-1202014-12-22
00803622164965Perfusion PackPerfusion Pack2026-10-22
00803622164804Perfusion PackPerfusion Pack2026-10-19
00803622164811Perfusion PackPerfusion Pack2026-10-19
00803622164842Perfusion PackPerfusion Pack2026-10-19
00803622164910Perfusion PackPerfusion Pack2026-10-19
00803622164927Perfusion PackPerfusion Pack2026-10-19
00803622164934Perfusion PackPerfusion Pack2026-10-19
00803622164941Perfusion PackPerfusion Pack2026-10-19
00803622164958Perfusion PackPerfusion Pack2026-10-19
00803622164989Perfusion PackPerfusion Pack2026-10-19
00803622164996Perfusion PackPerfusion Pack2026-10-19
00803622165047Perfusion PackPerfusion Pack2026-10-19
00803622165054Perfusion PackPerfusion Pack2026-10-19
00803622103001Cardioplegia cannulaAR-xxxxx2015-07-16
00803622103018Cardioplegia cannulaAR-xxxxx2015-07-16
00803622103025Cardioplegia cannulaAR-xxxxx2015-07-16
00803622103032Cardioplegia cannulaAR-xxxxx2015-07-16
00803622103049Cardioplegia cannulaAR-xxxxx2015-07-16

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