BIPAL

Primary DI
20705032054963
Brand
BIPAL
Company
CORDIS CORPORATION
Model
502402M
Catalog number
502402M
Device description
BF BIPAL 7F 50CM 2.2MM MP-TIP
Published
2016-08-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DWETUBING, PUMP, CARDIOPULMONARY BYPASS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWETubing, Pump, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K933235000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K933235000CORDIS BIPAL 7 /BIOPSY & BIPAL BIOPSY FORCEPS, MODIFCordis Corp.1994-01-06DWZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705032054963PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503205496320705032054963

GMDN Terms#

Term, Definition table
TermDefinition
Endomyocardial biopsy forceps, single-useA sterile grasping instrument designed to obtain tissue samples from the inner walls of the heart (endomyocardium) typically for histopathological examination. It is typically a flexible metal coil or plastic tube with a pair of scissors-like cups with cutting edges around their rims at the distal end which are operated by a handle attached at the proximal end. It is usually introduced percutaneously through the jugular vein or femoral artery (during catheterization). Acquired tissue samples are typically used for assessment of early rejection of a transplanted heart, cardiomyopathy and myocarditis diagnosis, or detection of antracycline cardiotoxicity. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not use if package is damanged
Special Storage Condition, Specify00Store in cool, dark, dry place
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
806136177
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705032000512AVANTI+402604T402604T2016-08-01
10705032000550AVANTI402605R402605R2016-08-01
10705032000772AVANTI+402611T402611T2016-08-01
10705032009751AVANTI504404X504404X2016-08-01
10705032009782AVANTI504407X504407X2016-08-01
10705032009805AVANTI504409X504409X2016-08-01
10705032009812AVANTI504504S504504S2016-08-01
10705032009829AVANTI504505S504505S2016-08-01
10705032009836AVANTI504505X504505X2016-08-01
10705032009843AVANTI504506S504506S2016-08-01
10705032009850AVANTI504506X504506X2016-08-01
10705032009867AVANTI504507X504507X2016-08-01
10705032009874AVANTI504508X504508X2016-08-01
10705032009928AVANTI504604T504604T2016-08-01
10705032009973AVANTI504605T504605T2016-08-01
10705032010009AVANTI504606D504606D2016-08-01
10705032010016AVANTI504606P504606P2016-08-01
10705032010023AVANTI504606S504606S2016-08-01
10705032010030AVANTI504606T504606T2016-08-01
10705032010054AVANTI504606X504606X2016-08-01

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