FDA.reportPublic FDA data

NA

Primary DI
10886704064947
Brand
NA
Company
Medos International Sàrl
Model
91-4205US
Catalog number
914205US
Device description
Control Unit Includes: Control Unit;Hardware Key;Carrying Case Keys 2 ; Adapters 3; Battery Charger; USB Cable;Information Manuals and Carrying Case
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
LKKPUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886704071426Direct MarkingGS10
10886704064947PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088670407142610886704071426
1088670406494710886704064947

GMDN Terms#

Term, Definition table
TermDefinition
Infusion pump programmerAn external device that enables a user to interrogate, test, analyse and program, noninvasively, one or more of the operating parameters (the programs) of an implanted infusion pump. It is able to read stored parameters in the infusion pump, providing historic and/or current information regarding performance, and may be used to upload new software into the infusion pump. It is a dedicated device, typically with an electronic wand with a communication antenna, connected to a port of a personal computer (PC) using dedicated software to drive the electronics of the wand to communicate with the implanted infusion pump.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius30 Degrees Celsius
Handling Environment Temperature41 Degrees Fahrenheit86 Degrees Fahrenheit
Storage Environment Humidity10 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature41 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
482661753
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705034165448COUGAR1891555141891555142015-09-24
10705034189017VG22733401002733401002016-12-31
10705034192802SUMMIT2746280002746280002016-12-31
10705034195278DISCOVERY2757200002757200002016-12-31
10705034199368EXPEDIUM2797224602797224602016-12-31
10705034224817UNIPLATE2897110002897110002016-12-31
10705034204246KEYSTONE2821040002821040002016-11-18
10705034060835BENGAL1773061221773061222015-09-24
10705034060866BENGAL1773061281773061282015-09-24
10705034161372COUGAR1891304101891304102015-09-24
10705034162973COUGAR1891404141891404142015-09-24
10705034163345COUGAR1891408121891408122015-09-24
10705034163369COUGAR1891408141891408142015-09-24
10705034163383COUGAR1891408161891408162015-09-24
10705034163499COUGAR1891451141891451142015-09-24
10705034163581COUGAR1891452101891452102015-09-24
10705034163604COUGAR1891452121891452122015-09-24
10705034163628COUGAR1891452141891452142015-09-24
10705034164168COUGAR1891458161891458162015-09-24
10705034164212COUGAR1891501081891501082015-09-24

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