FDA.reportPublic FDA data

Wolf-Pak

Primary DI
00857800006011
Brand
Wolf-Pak
Company
NDC HOMECARE LLC
Model
RF5000
Catalog number
RF5000
Device description
"IV SET 20D 92"" FLO REG Y 50/CS"
Published
2022-10-13
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

Product Codes#

Code, Name table
CodeName
FPASet, Administration, Intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857800006318PackageGS150In Commercial Distribution
00857800006011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857800006318008578000063188578000063180857800006318
00857800006011008578000060118578000060110857800006011

GMDN Terms#

Term, Definition table
TermDefinition
Basic intravenous administration set, noninvasiveA collection of noninvasive devices intended to conduct fluids from an intravenous (IV) administration bag/bottle to a peripheral venous cannula (not included) during gravitational or pump administration to a patient's venous system; some types may in addition be intended for enteral feeding applications. It typically includes tubing, connectors, chambers, and clamps; the bag/bottle may be included. It neither includes devices intended for invasive use nor a heat exchanger. This is a single-use device.

Regulatory Flags#

DUNS number
939966016
Device count
1
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850050591030MediFloWP-MDL300060WP-MDL3000602025-07-30
00857800006073MediFloWP-MDE101000-5WP-MDE101000-52025-07-30
00857800006202MediFloWP-MDE102000-5WP-MDE102000-52025-07-30
00850007185046MediFloMDE402000WP-MDE4020002020-11-23
00850007185220MediFloMDL270002WP-MDL2700022020-11-23
00857800006318Wolf-PakRF5000RF50002022-10-13
00850007185008MediFloMDE401000MDE4010002020-11-23
00850007185015MediFloMDC270010MDC2700102020-11-23
00850007185022MediFloMDC270050MDC2700502020-11-23
00850007185039MediFloMDC100020MDC1000202020-11-23
00850007185053MediFloMDE502500MDE5025002020-11-23
00850007185060MediFloMDL270010MDL2700102020-11-23
00850007185077MediFloMDL270001MDL2700012020-11-23
00850007185084MediFloMDE250100MDE2501002020-11-23
00850007185091MediFloMDL100002MDL1000022020-11-23
00850007185107MediFloMDL270005MDL2700052020-11-23
00850007185114MediFloMDE100500MDE1005002020-11-23
00850007185121MediFloMDC270020MDC2700202020-11-23
00850007185138MediFloMDE250500MDE2505002020-11-23
00850007185145MediFloMDL500020MDL5000202020-11-23

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Primary DI, Brand, Company table
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08498840006535VYGONVygon CorporationFPA2020-03-12
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