FDA.reportPublic FDA data

WalkMed Infusion

Primary DI
00859695006084
Brand
WalkMed Infusion
Company
WALKMED TECHNOLOGIES, LLC
Model
202750
Device description
FPS-600 Pump tubing set with 0.2 micron filter for WalkMed infusion pump, 170cm, proximal
Published
2025-09-12
Public version status
New
Distribution status
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
FPASet, Administration, Intravascular
FPBFilter, Infusion Line

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2
FPBFilter, Infusion LineGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K873961000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K873961000INFUMED 300 AMBULATORY INFUSION PUMPMed Fusion Systems, Inc.1987-12-29FRN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859695006091PackageGS110In Commercial Distribution
00859695006084PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859695006091008596950060918596950060910859695006091
00859695006084008596950060848596950060840859695006084

GMDN Terms#

Term, Definition table
TermDefinition
Electric infusion pump administration set, single-useA collection of sterile devices (e.g., plastic tubing, check valve, roller clamp, Y-site connector, Luer, needle/catheter) intended to be used in combination with an electrically-powered infusion pump for the intravenous (IV), subcutaneous, intramuscular, or epidural administration of medication. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length170Centimeter
Pore Size0.2Micrometer

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-34.4 Degrees Celsius54.4 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
101849686
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
00859695006091WalkMed Infusion2027502025-09-12
00859695006008WalkMed®202659PS400/3002016-09-24
00859695006015WalkMed®202747PS-3602016-09-24
00859695006022WalkMed®203728EFV-101B2016-09-24
00859695006039WalkMed®204383FPS-5602016-09-24
00859695006046WalkMed®204820IPR-862016-09-24
00859695006053WalkMed®204821IPR-1502016-09-24
00859695006060WalkMed®204822IPR-2502016-09-24
00859695006077WalkMed®204609WalkMed 350VL2016-09-24

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08426314391481GRI-BAGLABORATORIOS GRIFOLS SAFPB2021-10-26
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07613117017521Soft-Release-MicroYpsomed AGFPA2020-09-15
08498840006535VYGONVygon CorporationFPA2020-03-12
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08498840000014VYGONVygon CorporationFPA2017-07-28