FDA.reportPublic FDA data

Monoject

Primary DI
20884521155746
Brand
Monoject
Company
Cardinal Health, Inc.
Model
8881135609
Catalog number
8881135609
Device description
35 mL Syringe Barrel Assembly
Published
2018-06-27
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
KDCINSTRUMENT, SURGICAL, DISPOSABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDCInstrument, Surgical, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521155746PackageGS1150In Commercial Distribution
10884521155749PrimaryGS10
30884521155743Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452115574620884521155746
1088452115574910884521155749
3088452115574330884521155743

GMDN Terms#

Term, Definition table
TermDefinition
Irrigation syringeA general-purpose device used primarily for the flushing of body orifices with an irrigating solution. It may be designed with (e.g., a rigid plastic barrel with a fitted rubber bulb at one end and a nozzle at the other). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume35Milliliter

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
080935429
Device count
10
DM exempt
false
Premarket exempt
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884527009954Kendall30781747307817472018-06-23
30884527004748Kendall5000736150007361-2016-09-24
10884521021105MonojectSC5008XSC5008X2016-10-20
10884521021112MonojectSC6011XSC6011X2016-10-20
20884521152066Devon31145660311456602016-09-24
20884521152073Devon31145678311456782016-09-24
20884521152080Devon31145686311456862016-09-24
20884521152097Devon31145694311456942016-09-24
20884521152103Devon31145702311457022016-09-24
20884521152110Devon31145710311457102016-09-24
20884521152127Devon31145728311457282016-09-24
20884527020529Argyle888816035888881603582016-09-28
10884521000711Argyle888875001888887500182016-09-24
10884521000735Argyle888875051388887505132016-09-24
10884521011502Kangaroo888474121288847412122016-09-24
10884521011519Kangaroo888474121588847412152016-09-24
10884521011526Kangaroo888474122088847412202016-10-20
10884521011533Kangaroo888474122588847412252016-09-24
10884521011557Kangaroo888474123588847412352016-09-24
10884521011595Kangaroo888474164988847416492016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00887482138373SterionASPEN SURGICAL PRODUCTS, INC.KDC2026-02-15
10653160391098Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDC2025-12-19
06946480584224Disposable Skin Staple Removers Sinolinks Medical Innovation Co., Ltd.KDC2025-09-04
00194613020576MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613043209MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613044381MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613044633MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613045296MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613045302MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613045531MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613047153MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613054250MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613054441MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613054472MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613054496MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613054571MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613054762MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613062163MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613088026MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613088101MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613088118MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613088132MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613088194MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613089672MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613089757MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613089764MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613090890MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613091330MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613091774MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613093228MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01