Bigger Better-Bladder

Primary DI
00851997007011
Brand
Bigger Better-Bladder
Company
CIRCULATORY TECHNOLOGY INC
Model
BBB38
Catalog number
BBB38
Published
2016-10-03
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
DTNRESERVOIR, BLOOD, CARDIOPULMONARY BYPASS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTNReservoir, Blood, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K981284000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K981284000BETTER-BLADDER (BB)Circulatory Technology, Inc.1998-08-12DTN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851997007011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851997007011008519970070118519970070110851997007011

GMDN Terms#

Term, Definition table
TermDefinition
Cardiotomy reservoirA device intended to be integrated within an extracorporeal circuit to collect, store, and filter blood typically during a cardiopulmonary bypass procedure; it does not include additional functional components such as an oxygenator. It is typically a hardshell or soft, bag-like container with connectors designed to trap micro-particles and air bubbles for a period of time (e.g., 6 hours) and hold a reserve supply of blood; some types may also defoam. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter0.375Inch

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(516)624-2424ytamari@cirtec.com

Regulatory Flags#

DUNS number
786778944
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851997007004Better-BladderBB14BB142016-10-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08033178114042XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178114059XTRASORIN GROUP ITALIA SRLDTN2024-12-20
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08033178114103XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178114110XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178114127XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178114134XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178114141XTRASORIN GROUP ITALIA SRLDTN2024-12-20