FDA.reportPublic FDA data

LMA

Primary DI
15060112312301
Brand
LMA
Company
TELEFLEX INCORPORATED
Model
IPN046429
Catalog number
MC0050XLSK5-CP
Device description
AF 550 x 5ML/H FH 5" SAT C,4"IN
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

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
15060112312301PackageGS15In Commercial Distribution
05060112312304PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1506011231230115060112312301
05060112312304050601123123045060112312304

GMDN Terms#

Term, Definition table
TermDefinition
Elastomeric infusion pump kitA collection of sterile devices designed to enable a healthcare provider or patient to perform infusion therapy using an elastomeric infusion pump. The kit typically consists of the infusion pump and other devices such as a catheter, tunneller, needle, sheath, syringe, dressings, adhesive strips, and a filling device for the infusion pump. This device is typically used for the infusion of fluids, antibiotics, chemotherapeutic agents, or pain management medications in the healthcare facility or the home. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Away from Direct Sun Light, Storage Temp 10 deg C - 30 deg C , Humidity 20-65 % RH

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20801902219385ARROWEDC-00622EDC-006222026-03-24
30801902219405ARROWEDC-00820EDC-008202026-03-24
20801902219415ARROWEDC-00822EDC-008222026-03-24
20801902219460ARROWEDC-00818-MEDC-00818-M2026-03-24
20801902219484ARROWEDC-00622-HCEDC-00622-HC2026-03-24
20801902219514ARROWEDC-00822-HCEDC-00822-HC2026-03-24
20801902193418ARROWIPN920120AW-04432-N2026-03-23
30841156103983SUPERCROSS530253022026-03-23
20841156103993SUPERCROSS530353032026-03-23
20841156104006SUPERCROSS530453042026-03-23
20841156104013SUPERCROSS530553052026-03-23
20841156104020SUPERCROSS530653062026-03-23
20841156104037SUPERCROSS530753072026-03-23
20841156104044SUPERCROSS530853082026-03-23
30841156104058SUPERCROSS530953092026-03-23
24026704941494PILLINGP12797P127972026-03-23
24026704941500PILLINGP12805P128052026-03-23
24026704941555PILLINGP13063P130632026-03-23
24026704941562PILLINGP13065P130652026-03-23
24026704941579PILLINGP13081P130812026-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
48859299198123SMARTeZ Pump KVOEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDMEB2026-02-03
48859299198130SMARTeZ Pump KVOEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDMEB2026-02-03
28859299198143SMARTeZ Pump KVOEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDMEB2026-02-03
18859299101177SMARTeZ PumpEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDMEB2025-11-14
78859299100042SMARTeZ PumpEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDMEB2025-11-14
48859299198116SMARTeZ Pump KVOEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDMEB2025-09-11
00850050591030MediFloNDC HOMECARE LLCMEB2025-07-30
00857800006073MediFloNDC HOMECARE LLCMEB2025-07-30
00857800006202MediFloNDC HOMECARE LLCMEB2025-07-30
58859299121715SMARTeZ PumpEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDMEB2025-06-11
58859299121722SMARTeZ PumpEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDMEB2025-06-11
10810110920290IMed ProductsINTEGRATED MEDICAL SYSTEMS, INC.MEB2025-04-16
10810110920306IMed ProductsINTEGRATED MEDICAL SYSTEMS, INC.MEB2025-04-16
60810110920318IMed ProductsINTEGRATED MEDICAL SYSTEMS, INC.MEB2025-04-16
60810110920325IMed ProductsINTEGRATED MEDICAL SYSTEMS, INC.MEB2025-04-16
10810110920337IMed ProductsINTEGRATED MEDICAL SYSTEMS, INC.MEB2025-04-16
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10810110920368IMed ProductsINTEGRATED MEDICAL SYSTEMS, INC.MEB2025-04-16
10810110920375IMed ProductsINTEGRATED MEDICAL SYSTEMS, INC.MEB2025-04-16
10810110920382IMed ProductsINTEGRATED MEDICAL SYSTEMS, INC.MEB2025-04-16
10810110920399IMed ProductsINTEGRATED MEDICAL SYSTEMS, INC.MEB2025-04-16
10810110920405IMed ProductsINTEGRATED MEDICAL SYSTEMS, INC.MEB2025-04-16
10810110920412IMed ProductsINTEGRATED MEDICAL SYSTEMS, INC.MEB2025-04-16
10810110920429IMed ProductsINTEGRATED MEDICAL SYSTEMS, INC.MEB2025-04-16
10810110920436IMed ProductsINTEGRATED MEDICAL SYSTEMS, INC.MEB2025-04-16
10810110920443IMed ProductsINTEGRATED MEDICAL SYSTEMS, INC.MEB2025-04-16
10810110920450IMed ProductsINTEGRATED MEDICAL SYSTEMS, INC.MEB2025-04-16
10810110920467IMed ProductsINTEGRATED MEDICAL SYSTEMS, INC.MEB2025-04-16
60810110920486IMed ProductsINTEGRATED MEDICAL SYSTEMS, INC.MEB2025-04-16