FDA.reportPublic FDA data

CODMAN

Primary DI
10886704043829
Brand
CODMAN
Company
Cerenovus, Inc.
Model
AP-09150
Catalog number
AP09150
Device description
3000 Series High Temperature Drape for use with CODMAN O.R. Heater AP-09100
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
P890055012
P890055017
P890055021
P890055023
P890055027

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P890055012MEDSTREAM PROGRAMMABLE INFUSION PUMP SYSTEMIntera Oncology1996-03-11LKK
P890055017MEDSTREAM PROGRAMMABLE INFUSION PUMP SYSTEMIntera Oncology1996-03-11LKK
P890055021MEDSTREAM PROGRAMMABLE INFUSION PUMP SYSTEMIntera Oncology1996-03-11LKK
P890055023MEDSTREAM PROGRAMMABLE INFUSION PUMP SYSTEMIntera Oncology1996-03-11LKK
P890055027MEDSTREAM PROGRAMMABLE INFUSION PUMP SYSTEMIntera Oncology1996-03-11LKK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20886704043826PackageGS15Not in Commercial Distribution
10886704043829PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088670404382620886704043826
1088670404382910886704043829

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
Handling Environment Temperature-20 Degrees Celsius40 Degrees Celsius
Special Storage Condition, Specify00Do not use if opened or damaged.
Storage Environment Temperature-20 Degrees Celsius40 Degrees Celsius

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
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886704085317TRUFILL632500NA632500NA2023-10-23
10886704085324TRUFILL632400NA632400NA2023-10-23
10886704029144TRUFILL631-400631-4002014-09-20
10886704029151TRUFILL631-500631-5002014-09-20
10886704086017CEREGLIDESBC92114UGSBC92114UG2024-06-20
10886704086048CEREGLIDESBC92122UGSBC92122UG2024-06-20
10886704086079CEREGLIDESBC92130UGSBC92130UG2024-06-20
10886704086109CEREGLIDESBC92135UGSBC92135UG2024-06-20
10886704088097CEREGLIDECS71125UCS71125U2025-10-13
10886704088103CEREGLIDECS71115UCS71115U2025-10-13
10886704088110CEREGLIDECS71137UCS71137U2025-10-13
10886704088141CEREGLIDECS71132UCS71132U2025-10-13
10886704086437CEREGLIDENIC42132UNIC42132U2025-09-26
10886704086451CEREGLIDENIC42144UNIC42144U2025-09-26
10886704086475CEREGLIDENIC42160UNIC42160U2025-09-26
10886704086499CEREGLIDENIC57115UNIC57115U2025-09-26
10886704086512CEREGLIDENIC57125UNIC57125U2025-09-26
10886704086536CEREGLIDENIC57132UNIC57132U2025-09-26
10886704086550CEREGLIDENIC57137UNIC57137U2025-09-26
10886704086598CEREGLIDENIC42125U2025-09-26

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