FDA.reportPublic FDA data

WalkMed®

Primary DI
00859695006039
Brand
WalkMed®
Company
WALKMED TECHNOLOGIES, LLC
Model
204383
Catalog number
FPS-560
Device description
Pump Tubing Set with 0.2 micron filter for WalkMed Infusion Pump, 170 cm
Published
2016-09-24
Public version status
Update
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10859695006036PackageGS110In Commercial Distribution
00859695006039PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085969500603610859695006036
00859695006039008596950060398596950060390859695006039

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
303-420-9569walkmedquality@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
00859695006084WalkMed Infusion2027502025-09-12
00859695006091WalkMed Infusion2027502025-09-12
00859695006008WalkMed®202659PS400/3002016-09-24
00859695006015WalkMed®202747PS-3602016-09-24
00859695006022WalkMed®203728EFV-101B2016-09-24
00859695006046WalkMed®204820IPR-862016-09-24
00859695006053WalkMed®204821IPR-1502016-09-24
00859695006060WalkMed®204822IPR-2502016-09-24
00859695006077WalkMed®204609WalkMed 350VL2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08436020769184DOSI-FLOWLEVENTON SAUFPA2023-09-08
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08426314391412GRI-BAGLABORATORIOS GRIFOLS SAFPB2021-10-26
08426314391474GRI-BAGLABORATORIOS GRIFOLS SAFPB2021-10-26
08426314391481GRI-BAGLABORATORIOS GRIFOLS SAFPB2021-10-26
07613117017422Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017446Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017460Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017484Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017507Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017521Soft-Release-MicroYpsomed AGFPA2020-09-15
08498840009338VYGONVygon CorporationFPA2020-04-21
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08498840006535VYGONVygon CorporationFPA2020-03-12
08498840000014VYGONVygon CorporationFPA2017-07-28
08498840009833VYGONVygon CorporationFPA2017-07-28
08498840010310VYGONVygon CorporationFPB2017-07-28
08498840010327VYGONVygon CorporationFPB2017-07-28
08498840001172VYGONVygon CorporationFPA2017-07-05
08426314580816GRI-BAGLABORATORIOS GRIFOLS SAFPB2017-04-05
08426314583503GRI-BAGLABORATORIOS GRIFOLS SAFPB2017-04-05
08426314604031GRI-BAGLABORATORIOS GRIFOLS SAFPB2017-04-05
08426314575683GRI-BAGLABORATORIOS GRIFOLS SAFPB2017-04-05
08426314575690GRI-BAGLABORATORIOS GRIFOLS SAFPB2017-04-05
08426314580823GRI-BAGLABORATORIOS GRIFOLS SAFPB2017-04-05
08426314604024GRI-BAGLABORATORIOS GRIFOLS SAFPB2017-04-05
08426314546836GRI-BAGLABORATORIOS GRIFOLS SAFPB2017-01-02