FDA.reportPublic FDA data

AutoFuser

Primary DI
08806139603905
Brand
AutoFuser
Company
Ace Medical Co., Ltd.
Model
MC0080XL
Device description
550/8.0
Published
2016-11-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18806139603902PackageGS110In Commercial Distribution
58806139603900PackageGS150In Commercial Distribution
08806139603905PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1880613960390218806139603902
5880613960390058806139603900
08806139603905088061396039058806139603905

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
688030865
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
08806139603608AutoFuserMC0020L2016-11-08
08806139603615AutoFuserMC0020M2016-11-08
08806139603622AutoFuserMC0040L2016-11-08
08806139603639AutoFuserMC0050L2016-11-08
08806139603646AutoFuserMC0050XL2016-11-08
08806139603653AutoFuserMT2060L 2016-11-08
08806139603660AutoFuserMT2060M2016-11-08
08806139603677AutoFuserMT4030L2016-11-08
08806139603684AutoFuserMT4060L 2016-11-08
08806139603691AutoFuserMT4060XL2016-11-08
08806139603707AutoFuserMT5015L 2016-11-08
08806139603714AutoFuserMT5015XL2016-11-08
08806139603721AutoFuserMT5060L 2016-11-08
08806139603738AutoFuserMT5060XL 2016-11-08
08806139603745AutoFuserMX5060XL2016-11-08
08806139603752AutoFuserMT8015XL 2016-11-08
08806139603769AutoFuserMT8060XL2016-11-08
08806139603776AutoSelectorMVAL2016-11-08
08806139603783AutoSelectorMVAT60L2016-11-08
08806139603790AutoSelectorMVAX30XL2016-11-08

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
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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
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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
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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