FDA.reportPublic FDA data

WalkMed®

Primary DI
00859695006053
Brand
WalkMed®
Company
WALKMED TECHNOLOGIES, LLC
Model
204821
Catalog number
IPR-150
Device description
Pump Reservoir for WalkMed Infusion Pump, 150 mL
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
BTCBag, Reservoir

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTCBag, ReservoirAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10859695006050PackageGS110In Commercial Distribution
00859695006053PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085969500605010859695006050
00859695006053008596950060538596950060530859695006053

GMDN Terms#

Term, Definition table
TermDefinition
Parenteral/enteral solution bagA flexible pouch or sack designed to contain a solution of nutrients or medication for administration to a patient either parenterally (e.g., intravenously) or enterally (directly into the gastrointestinal tract). It is typically made of synthetic polymer materials. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume150Milliliter

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
00859695006039WalkMed®204383FPS-5602016-09-24
00859695006046WalkMed®204820IPR-862016-09-24
00859695006060WalkMed®204822IPR-2502016-09-24
00859695006077WalkMed®204609WalkMed 350VL2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04816415501430BREATHING BAG single use 500ASSOMEDIKA, OOOBTC2026-05-27
04816415501447BREATHING BAG single use 1000ASSOMEDIKA, OOOBTC2026-05-27
04816415501454BREATHING BAG single use 2000ASSOMEDIKA, OOOBTC2026-05-27
04816415501461BREATHING BAG single use 3000ASSOMEDIKA, OOOBTC2026-05-27
04816415501478BREATHING BAG reusable 500ASSOMEDIKA, OOOBTC2026-05-27
04816415501485BREATHING BAG reusable 1000ASSOMEDIKA, OOOBTC2026-05-27
04816415501492BREATHING BAG reusable 2000ASSOMEDIKA, OOOBTC2026-05-27
04816415501508BREATHING BAG reusable 3000ASSOMEDIKA, OOOBTC2026-05-27
08697645018198ENDURE INDUSTRIESENDURE INDUSTRIESBTC2026-04-17
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10885632455414Halyard Breathing BagAIRLIFEBTC2025-07-18
10885632455421Halyard Breathing BagAIRLIFEBTC2025-07-18
10629160000346FEATHER-FLEXBOMImed IncBTC2025-07-14
10629160000339FEATHER-FLEXBOMImed IncBTC2024-03-01
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