FDA.report

Monoject

Primary DI
20884521189635
Brand
Monoject
Company
Cardinal Health, Inc.
Model
1186000555T
Catalog number
1186000555T
Device description
60 mL Syringe,Regular Tip
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
FMFSyringe, piston

Product Code Classifications

CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20884521189635PackageGS130In Commercial Distribution
30884521189632PackageGS1360In Commercial Distribution
10884521189638PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2088452118963520884521189635
3088452118963230884521189632
1088452118963810884521189638

GMDN Terms

TermDefinition
Metered-delivery hypodermic syringeA sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. The application of the content of this device may be in conjunction with an injector device (transcutaneous delivery) or through the traditional use of a needle (subcutaneous delivery). It may allow for retraction of an attached needle (safety syringe); the needle is not included. This is a single-use device.

Device Sizes

TypeValueUnit
Total Volume60Milliliter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep dry; This side up;AVOID DIRECT SUNLIGHT

Sterilization Methods

Method

Regulatory Flags

DUNS number
080935429
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
20884521014937Monoject888151111088815111102016-09-24
20884521014944Monoject888151113688815111362016-09-24
20884521025674Dover888473259888847325982016-09-24
20884527021434Kendall33503335032016-09-24
20884527021441Kendall33504335042016-09-24
20884527021458Kendall33505335052016-09-24
20884527021465Kendall33506335062016-09-24
20884527021472Kendall33507335072016-09-24
20884527021489Kendall33508335082016-09-24
20884527021502Kendall33510335102016-09-24
30884521012442Monoject888120231488812023142018-06-27
20884521012469Monoject888120232288812023222018-06-27
30884521012473Monoject888120233088812023302018-06-27
30884521012497Monoject888120234888812023482018-06-27
30884521012534Monoject888120237188812023712018-06-30
30884521012558Monoject888120238988812023892018-06-27
20884521012568Monoject888120239788812023972018-06-30
20884521142760Monoject10884521142763108845211427632018-06-29
00029369211032MCDAVIDMH794002112023-05-26
90884521162088Uni-PatchMH73912MH739122018-06-30

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