FDA.reportPublic FDA data

Cardiovascular Procedure Kit

Primary DI
50699753506676
Brand
Cardiovascular Procedure Kit
Company
Terumo Cardiovascular Systems Corporation
Model
76515
Published
2017-10-11
Public version status
Update
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
DTRHeat-Exchanger, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTRHeat-Exchanger, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K823451000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K823451000CLEAR CARDIOPLEJIA DELIVERY SYSTEM3M Health Care, Sarns1983-01-14DTR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50699753506676PackageGS12In Commercial Distribution
00699753506671PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5069975350667650699753506676
00699753506671006997535066716997535066710699753506671

GMDN Terms#

Term, Definition table
TermDefinition
Cardioplegia solution administration kitA collection of sterile devices intended to be used to inject cardioplegia solution into the heart to interrupt its contractions during cardiopulmonary bypass surgery. It typically consists of tubing/adaptor, a filter, and a heat exchanger. This is single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
177655466
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
00699753478145Cardiovascular Procedure Kit737182014-10-08
00699753537705Cardiovascular Procedure Kit73344-052026-07-22
00699753537712Cardiovascular Procedure Kit76212-012026-07-22
00699753537729Cardiovascular Procedure Kit787422026-07-22
00699753537736Cardiovascular Procedure Kit788032026-07-22
00699753537651Cardiovascular Procedure KitCX-CZ219X2026-07-20
00699753537668Cardiovascular Procedure KitCX-CZ220X2026-07-20
00699753537675Cardiovascular Procedure KitCX-CZ221X2026-07-20
00699753537682Cardiovascular Procedure KitCX-CZ222X2026-07-20
00699753537699Cardiovascular Procedure Kit788022026-07-20
00699753537569Cardiovascular Procedure Kit787872026-07-08
00699753537576Cardiovascular Procedure Kit786052026-07-08
00699753537583Cardiovascular Procedure Kit787902026-07-08
00699753537590Cardiovascular Procedure Kit670602026-07-08
00699753537606Cardiovascular Procedure Kit787772026-07-08
00699753537613Cardiovascular Procedure KitCX-IS1292026-07-08
00699753537521Cardiovascular Procedure Kit76434-042026-06-24
00699753537538Cardiovascular Procedure Kit786942026-06-24
00699753532038Cardiovascular Procedure Kit76273-022024-07-09
00699753531956Cardiovascular Procedure Kit76873-032024-07-07

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18051160302236Quantum PureFlow Standard Heat Exchanger Low Flow 3/16 WSPECTRUM MEDICAL SRLDTR2025-12-23
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08033178114288VanguardSORIN GROUP ITALIA SRLDTR2025-10-31
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18051160302205Quantum PureFlow Standard Heat Exchanger High Flow 3/8 WSPECTRUM MEDICAL SRLDTR2024-11-19
18051160302267Quantum PureFlow Cardioplegia Heat Exchanger High Flow 1/4 WSPECTRUM MEDICAL SRLDTR2024-11-19
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