FDA.reportPublic FDA data

Sarns™ Cardioplegia Set

Primary DI
50699753002000
Brand
Sarns™ Cardioplegia Set
Company
Terumo Cardiovascular Systems Corporation
Model
16200
Published
2015-10-02
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
KRIAccessory Equipment, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRIAccessory Equipment, Cardiopulmonary BypassCardiovascular1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K810079000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K810079000SARNS INTEGRATED CARDIOPLEGIA DELIV. SYS3M Health Care, Sarns1981-01-30KRI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50699753002000PackageGS14In Commercial Distribution
00699753002005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5069975300200050699753002000
00699753002005006997530020056997530020050699753002005

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
00699753537811Cardiovascular Procedure KitCX-PL1642026-08-17
00699753537828Cardiovascular Procedure KitCX-PL1652026-08-17
00699753537743Cardiovascular Procedure Kit788052026-08-03
00699753537750Cardiovascular Procedure Kit788122026-08-03
00699753537767Cardiovascular Procedure Kit786712026-08-03
00699753530638Cardiovascular Procedure Kit75972-022024-02-22
00699753532625Cardiovascular Procedure Kit783422024-08-09
00699753532311Cardiovascular Procedure Kit74737-022024-07-22
00699753532083Cardiovascular Procedure Kit77746-012024-07-09
00699753531734Cardiovascular Procedure Kit76373-022024-06-12
00699753531673Cardiovascular Procedure Kit74101-012024-06-07
00699753530492Cardiovascular Procedure Kit74005-032024-02-15
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

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