FDA.reportPublic FDA data

MediFlo

Primary DI
00850007185008
Brand
MediFlo
Company
NDC HOMECARE LLC
Model
MDE401000
Catalog number
MDE401000
Device description
MEDIFLO 400ML VOL/100ML HR 24/CS
Published
2020-11-23
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
MEBPump, Infusion, Elastomeric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MEBPump, Infusion, ElastomericGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151650000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151650000SMARTez elastomeric infusion pumpEpic Medical Pte. , Ltd.2016-04-04MEB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850007185005PackageGS124In Commercial Distribution
00850007185008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000718500510850007185005
00850007185008008500071850088500071850080850007185008

GMDN Terms#

Term, Definition table
TermDefinition
Elastomeric infusion pump systemAn assembly of devices that provides continuous and/or intermittent percutaneous infusion of a prescribed medicated solution to a patient through forces from elastic material. It typically consists of an elastomeric chamber (various sizes predetermine the flow and volume) that is filled with the solution using a dedicated filling device and/or syringe to create a pressure, tubing, particulate/air-eliminating filter, a flow restrictor, and a connector at the distal end for connection to the patient's access device. It may be used for general infusion, antibiotic delivery, chemotherapy, or pain management in either a healthcare facility or in the home. This is a single-use device.

Regulatory Flags#

DUNS number
939966016
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No 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
00857800006011Wolf-PakRF5000RF50002022-10-13
00857800006318Wolf-PakRF5000RF50002022-10-13
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10612479280189McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
10612479280202McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
10612479280226McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
10612479280240McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
10612479280264McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
10612479280288McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
10612479280301McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
10612479280325McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
10612479280349McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
10612479280363McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
10612479280387McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
10612479280400McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
10612479280424McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
10612479280448McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
10612479280462McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
10612479271323McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2024-07-20
10612479271347McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2024-07-20
10612479271361McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2024-07-20
10612479271385McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2024-07-20
10612479271408McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2024-07-20
10612479271422McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2024-07-20
10612479271446McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2024-07-20
10612479271460McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2024-07-20
10612479271484McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2024-07-20
10612479271507McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2024-07-20
10612479271521McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2024-07-20
10612479271545McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2024-07-20
08436020766404DOSI-PAINLEVENTON SAUMEB2018-12-31
08436020766411DOSI-PAINLEVENTON SAUMEB2018-12-31
08436020766428DOSI-PAINLEVENTON SAUMEB2018-12-31