FDA.reportPublic FDA data

WalkMed®

Primary DI
00859695006077
Brand
WalkMed®
Company
Walkmed Infusion LLC
Model
204609
Catalog number
WalkMed 350VL
Device description
Ambulatory Infusion Pump
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRNPump, Infusion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRNPump, InfusionGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859695006077PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859695006077008596950060778596950060770859695006077

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose infusion pump, battery-poweredA battery-powered ambulatory device intended to provide continuous or intermittent administration of non-specific drugs and/or solutions. It consists of a small unit with a pumping mechanism and an infusion-rate controller, and is used with a dedicated single-use medication cartridge (not included). It is used with a suitable injection/infusion set for delivery via an intravenous, subcutaneous, arterial, epidural or intracavital route. It is typically worn in a case attached to the belt or carried in a pocket and may be used in a healthcare setting or in the home.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-10 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
303-420-9569walkmedquality@walkmed.net

Regulatory Flags#

DUNS number
948594726
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10859695006005WalkMed®202659PS400/3002016-09-24
10859695006012WalkMed®202747PS-3602016-09-24
10859695006029WalkMed®203728EFV-101B2016-09-24
00859695006039WalkMed®204383FPS-5602016-09-24
00859695006046WalkMed®204820IPR-862016-09-24
00859695006053WalkMed®204821IPR-1502016-09-24
00859695006060WalkMed®204822IPR-2502016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885403211423Alaris™ Pump Module, Model 8100CAREFUSION 303, INC.FRN2025-12-19
10885403423208Alaris™ Syringe Module, Model 8110CAREFUSION 303, INC.FRN2025-12-19
00816989021468HK Klein Infiltration Pump+HK SURGICAL INC.FRN2025-09-29
50197886011239Novum IQBAXTER HEALTHCARE CORPORATIONFRN2025-08-25
50197886013172Novum IQBAXTER HEALTHCARE CORPORATIONFRN2025-08-25
50197886013189Novum IQBAXTER HEALTHCARE CORPORATIONFRN2025-08-25
50197886013196Novum IQBAXTER HEALTHCARE CORPORATIONFRN2025-08-25
00850017421202RemunityPROUnited Therapeutics CorporationFRN2025-08-07
00850017421219RemunityPROUnited Therapeutics CorporationFRN2025-08-07
00850017421226RemunityPROUnited Therapeutics CorporationFRN2025-08-07
00850017421233RemunityPROUnited Therapeutics CorporationFRN2025-08-07
00850017421240RemunityPROUnited Therapeutics CorporationFRN2025-08-07
00850017421264RemunityPROUnited Therapeutics CorporationFRN2025-08-07
00850017421271RemunityPROUnited Therapeutics CorporationFRN2025-08-07
20197886008214Novum IQBAXTER HEALTHCARE CORPORATIONFRN2025-07-07
10885403519291BD AlarisCAREFUSION 303, INC.FRN2025-06-25
M335400011ICU Medical, INC.ICU MEDICAL, INC.FRN2025-04-28
M335400031ICU Medical, INC.ICU MEDICAL, INC.FRN2025-04-28
B510IP200ADVANCED INFUSION PUMPADVANCED INSTRUMENTATIONS, INC.FRN2025-02-04
00811505030467Ivenix Infusion SystemFresenius Kabi AGFRN2024-12-06
05713495001043VYAFUSER™Phillips-Medisize A/SFRN2024-11-13
27290109155306Sapphire M.T. Pump Kit CEITAN MEDICAL LTDFRN2024-09-04
00816989021437HK Klein TDD PumpHK SURGICAL INC.FRN2024-08-29
10885403519284AlarisCAREFUSION 303, INC.FRN2024-05-24
40616258024415MEDRAD® Intego Patient Administration SetBayer Medical Care Inc.FRN2024-05-06
40616258024835MEDRAD® Intego Sterile DisposablesBayer Medical Care Inc.FRN2024-05-06
00862492000353Eitan MedicalOPTUMHEALTH CARE SOLUTIONS, INC.FRN2024-04-24
04987488102241PORT ACCESS INFUSION SETSB-KAWASUMI LABORATORIES, INC.FRN2024-04-12
04987488102258PORT ACCESS INFUSION SETSB-KAWASUMI LABORATORIES, INC.FRN2024-04-12
04987488102265PORT ACCESS INFUSION SETSB-KAWASUMI LABORATORIES, INC.FRN2024-04-12