FDA.report

LMA

Primary DI
15060112312110
Brand
LMA
Company
TELEFLEX INCORPORATED
Model
IPN046410
Catalog number
MC0020MSK2-CP
Device description
AF 100 x 2ML/H FH STD 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

Related Records

Contact Domains

Product Codes

CodeName
MEBPUMP, INFUSION, ELASTOMERIC

Product Code Classifications

CodeDeviceSpecialtyClass
MEBPump, Infusion, ElastomericGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
15060112312110PackageGS15In Commercial Distribution
05060112312113PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1506011231211015060112312110
05060112312113050601123121135060112312113

GMDN Terms

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

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

Contacts

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

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