FDA.reportPublic FDA data

Monoject

Primary DI
30884521102754
Brand
Monoject
Company
Cardinal Health, Inc.
Model
8881540111
Catalog number
8881540111
Device description
Needleless Med Prep Cannula
Published
2018-06-30
Public version status
Update
Distribution status
Not 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
GEACANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEACannula, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521102750PackageGS1100Not in Commercial Distribution
20884521102757PackageGS11000Not in Commercial Distribution
30884521102754PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452110275010884521102750
2088452110275720884521102757
3088452110275430884521102754

GMDN Terms#

Term, Definition table
TermDefinition
Medication transfer needle, non-filtering/non-ventedA slender, rigid, sharp or blunt metal tube intended to be attached to a syringe and typically used in the pharmacy to aspirate and transfer fluid medication from a vial/ampule to another container for medication preparation or other purposes. It consists of a short needle sufficient to penetrate the vial stopper and extract all the medication. It is typically of 20 gauge to provide a high-flow rate with minimum coring. It does not include a filter or a back-pressure venting feature. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry;AVOID DIRECT SUNLIGHT

Regulatory Flags#

DUNS number
080935429
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884527004676Argyle43309433092016-10-14
10884527005079Argyle43201432012016-09-24
10884527005086Argyle1604091604092016-09-24
10884527005147Argyle888816040888881604082016-09-24
10884527005215Argyle888816083888881608382016-09-24
10884527005222Argyle888816085388881608532016-09-24
20884527004680Argyle43311433112016-09-24
20884527020543Argyle888816044088881604402016-09-24
20884527020550Argyle888816045788881604572016-09-24
20884521012193Monoject888153576288815357622016-09-24
10884521022966Monoject8989PG28989PG22016-09-24
30884521019229SharpSafety882088202016-09-24
40884521022936Monoject8939PG28939PG22016-09-24
10884521190948Kangaroo384500W384500W2017-09-12
10884521190894Kangaroo3844003844002017-08-02
10884521544475Wings67093670932018-06-27
20884521544489Wings67095670952018-06-27
10884521023284Monoject8507SA8507SA2016-09-24
10884521208742Devon31145892311458922018-06-29
20884521154244Monoject8985PG2Y8985PG2Y2017-01-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G4531121L0PEAK MEDICALPeak Medical Distribution Inc.GEA2026-10-28
G4531121M0PEAK MEDICALPeak Medical Distribution Inc.GEA2026-10-28
G4531121S0PEAK MEDICALPeak Medical Distribution Inc.GEA2026-10-28
00810130456901Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130456918Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130456925Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130456932Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130456949Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130456956Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130456963Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130456970Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130456987Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130456994Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457007Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457014Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457021Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457038Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457045Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457052Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457069Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457076Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457083Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457106Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457113Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457120Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457137Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457144Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457168Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457175Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457182Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23