FDA.reportPublic FDA data

WalkMed Infusion

Primary DI
00859695006091
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
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FPASet, Administration, Intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral 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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
101849686
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859695006084WalkMed 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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