FDA.reportPublic FDA data

CODMAN® ACCU-FLO®

Primary DI
10381780517719
Brand
CODMAN® ACCU-FLO®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
821521
Catalog number
82-1521
Device description
CODMAN® ACCU-FLO® Connector, Three Way
Published
2020-02-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JXGShunt, central nervous system and components

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JXGShunt, Central Nervous System And ComponentsNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102961000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102961000HOLTER IN-LINE SHUNT FILTER, HOLTER CEREBRAL CATHETER RESERVOIR, ACCU-FLO CONNECTORS; ACCU-FLO THREE WAY CONNECTOR; CODMCodman & Shurtleff, Inc.2011-02-18JXG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780517719PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178051771910381780517719

GMDN Terms#

Term, Definition table
TermDefinition
Cerebrospinal fluid shunt connectorA sterile, implantable device intended to connect components of a cerebrospinal fluid (CSF) shunt assembly (e.g., ventriculoperitoneal shunt), designed to remove excess cerebrospinal fluid from around the central nervous system especially in the treatment of hydrocephalus. It is typically made of plastic or metal and is Y-shaped or straight. This is a single-patient device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
081277700
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780024507Integra® Jarit®100539100-5392018-01-22
10381780024514Integra® Jarit®100540100-5402018-01-22
10381780031901Integra® Miltex®27-20227-2022015-09-22
10381780031918Integra® Miltex®27-20427-2042015-09-22
10381780031925Integra® Miltex®27-20627-2062015-09-22
10381780031932Integra® Miltex®27-20827-2082015-09-22
10381780031949Integra® Miltex®27-21027-2102015-09-22
10381780031956Integra® Miltex®27-21227-2122015-09-22
10381780063865Integra® Miltex®4-515C4-515C2018-02-15
10381780063872Integra® Miltex®4-5224-5222018-02-15
10381780063896Integra® Miltex®461146112018-02-15
10381780063902Integra® Miltex®461546152018-02-15
10381780064206Integra® Miltex®33-3833-382018-02-14
10381780128779Integra® Miltex®30-174030-17402016-08-03
10381780133810Integra® Jarit®320437320-4372016-08-12
10381780134503Integra® Jarit®6531016531012018-01-15
10381780136408Integra® Jarit®X37254X372542016-08-14
10381780142874Integra® Jarit®230250230-2502016-08-14
10381780143048Integra® Jarit®320195320-1952016-08-14
10381780143055Integra® Jarit®320196320-1962016-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03760409441121SophysaSOPHYSAJXG2026-06-05
03760409441138SophysaSOPHYSAJXG2026-06-05
03760409441145SophysaSOPHYSAJXG2026-06-05
03760409441152SophysaSOPHYSAJXG2026-06-05
03760409441169SophysaSOPHYSAJXG2026-06-05
03760409441176SophysaSOPHYSAJXG2026-06-05
03760409441183SophysaSOPHYSAJXG2026-06-05
03760409441190SophysaSOPHYSAJXG2026-06-05
03760409441206SophysaSOPHYSAJXG2026-06-05
03760409441213SophysaSOPHYSAJXG2026-06-05
03760409441220SophysaSOPHYSAJXG2026-06-05
03760409441237SophysaSOPHYSAJXG2026-06-05
03760409441244SophysaSOPHYSAJXG2026-06-05
03760409441251SophysaSOPHYSAJXG2026-06-05
03760409441268SophysaSOPHYSAJXG2026-06-05
10381780535362CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535379CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535881CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535928CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535942CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535393CODMAN® CERTAS® PlusIntegra LifeSciences Switzerland SàrlJXG2024-11-20
10381780535430CODMAN® CERTAS® PlusIntegra LifeSciences Switzerland SàrlJXG2024-11-20
10381780535829CODMAN® CERTAS® PlusIntegra LifeSciences Switzerland SàrlJXG2024-11-20
10381780535867CODMAN® CERTAS® PlusIntegra LifeSciences Switzerland SàrlJXG2024-11-20
10381780536734CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-05-29
10381780536741CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-05-29
10381780536758CODMAN® ACCU-FLO®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-05-29
10381780536765CODMAN® ACCU-FLO®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-05-29
10381780536789CODMAN® ACCU-FLO®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-05-29
10381780536819CODMAN® ACCU-FLO®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-05-29