FDA.reportPublic FDA data

CODMAN

Primary DI
10886704072881
Brand
CODMAN
Company
Cerenovus, Inc.
Model
AP-04009
Catalog number
AP04009
Device description
Non-coring (Huber) Needle for use with CODMAN 3000 Series Drug Delivery System
Published
2014-09-20
Public version status
Update
Distribution status
Not 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
LKKPUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LKKPump, Infusion, Implanted, ProgrammableUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P890055021

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P890055021MEDSTREAM PROGRAMMABLE INFUSION PUMP SYSTEMIntera Oncology1996-03-11LKK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20886704072888PackageGS115Not in Commercial Distribution
10886704072881PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088670407288820886704072888
1088670407288110886704072881

GMDN Terms#

Term, Definition table
TermDefinition
Implantable intrathecal infusion pump, nonprogrammableA battery-powered nonprogrammable device designed to be implanted in a patient for the storing and subarachnoid administration of narcotics/drugs (e.g., morphine sulfate, baclofen) to manage intractable pain and muscle spasms of malignant or non-malignant origin. This implantable infusion pump (IIP) may enable delivery of a bolus of medication, typically patient-controlled with mechanical restrictions that limit the refill rate of the device, or it may provide a constant flow of medication at a factory-set rate. The device typically consists of a refillable drug reservoir, usually implanted under the skin of the lower abdomen, and a connected catheter placed into the spinal fluid space.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not use if opened or damaged.

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
607846297
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886704080428ENPOWERDCB2000500DCB20005002016-09-12
10886704082293CEREBASEGS9090SDGS9090SD2020-04-13
10886704082316CEREBASEGS9080SDGS9080SD2020-04-13
10886704082323CEREBASEGS9095SDGS9095SD2020-04-13
10886704076957DELTAFILLDLF100154DLF1001542016-11-16
10886704076971DELTAFILLDLF100250DLF1002502016-11-16
10886704076988DELTAFILLDLF100258DLF1002582016-11-16
10886704077022DELTAFILLDLF100208DLF1002082016-11-16
10886704077039DELTAFILLDLF100310DLF1003102016-11-16
10886704077046DELTAFILLDLF100308DLF1003082016-11-16
10886704077053DELTAFILLDLF100410DLF1004102015-09-20
10886704077060DELTAFILLDLF100408DLF1004082015-09-20
10886704077077DELTAFILLDLF100510DLF1005102016-11-16
10886704077176DELTAFILLDLF182260DLF1822602016-11-16
10886704077183DELTAFILLDLF182460DLF1824602016-11-16
10886704077244DELTAXSFTDLX100151DLX1001512015-09-20
10886704077251DELTAXSFTDLX100152DLX1001522015-09-20
10886704077268DELTAXSFTDLX100153DLX1001532015-09-20
10886704077275DELTAXSFTDLX100254DLX1002542015-09-20
10886704077282DELTAXSFTDLX100256DLX1002562015-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150021277NAMEDTRONIC, INC.LKK2026-05-02
00763000999414SYNCHROMED™ IIIMEDTRONIC, INC.LKK2026-01-15
00763000999421SYNCHROMED™ IIIMEDTRONIC, INC.LKK2026-01-15
00763000004101NAMEDTRONIC, INC.LKK2025-08-25
00763000574598NAMEDTRONIC, INC.LKK2025-02-10
00763000916633NAMEDTRONIC, INC.LKK2024-05-06
00763000916640NAMEDTRONIC, INC.LKK2024-05-06
00763000916657Ascenda®MEDTRONIC, INC.LKK2024-05-06
00763000916664Ascenda®MEDTRONIC, INC.LKK2024-05-03
00763000916671Ascenda®MEDTRONIC, INC.LKK2024-05-03
00763000825539NAMEDTRONIC, INC.LKK2024-03-30
00763000745073NAMEDTRONIC, INC.LKK2023-12-16
00763000597023SYNCHROMED™ IIIMEDTRONIC, INC.LKK2023-12-15
00763000597030SYNCHROMED™ IIIMEDTRONIC, INC.LKK2023-12-15
00763000825515NAMEDTRONIC, INC.LKK2023-12-09
00763000825522NAMEDTRONIC, INC.LKK2023-12-09
00763000852597Ascenda®MEDTRONIC, INC.LKK2023-12-09
00763000852603Ascenda®MEDTRONIC, INC.LKK2023-12-09
00763000852610Ascenda®MEDTRONIC, INC.LKK2023-12-09
00763000852627Ascenda®MEDTRONIC, INC.LKK2023-12-09
00763000852634Ascenda®MEDTRONIC, INC.LKK2023-12-09
00763000875725NAMEDTRONIC, INC.LKK2023-12-09
00763000875695NAMEDTRONIC, INC.LKK2023-11-16
00763000875701NAMEDTRONIC, INC.LKK2023-11-16
00763000875718NAMEDTRONIC, INC.LKK2023-11-16
00763000875862N'VISION™MEDTRONIC, INC.LKK2023-11-16
00763000632786NAMEDTRONIC, INC.LKK2023-11-05
00763000632793NAMEDTRONIC, INC.LKK2023-11-05
00763000631482NAMEDTRONIC, INC.LKK2023-03-10
00763000301354NAMEDTRONIC, INC.LKK2022-10-09