FDA.reportPublic FDA data

Monoject

Primary DI
30884521750177
Brand
Monoject
Company
Cardinal Health, Inc.
Model
8881570121D
Catalog number
8881570121D
Device description
Monoject™ 0.9% Sodium Chloride Prefilled Flush Syringe, 10ML Fill, 12ML Syringe
Published
2019-09-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
NGTSaline, vascular access flush

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NGTSaline, Vascular Access FlushGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521750170PackageGS130In Commercial Distribution
30884521750177PackageGS16In Commercial Distribution
10884521750173PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452175017020884521750170
3088452175017730884521750177
1088452175017310884521750173

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
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 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
08904379807890Easy FlushSPM MEDICARE PRIVATE LIMITEDNGT2026-03-07
18904379807927Easy FlushSPM MEDICARE PRIVATE LIMITEDNGT2026-03-07
18904379807934Easy FlushSPM MEDICARE PRIVATE LIMITEDNGT2026-03-07
08904379807968Easy FlushSPM MEDICARE PRIVATE LIMITEDNGT2026-03-07
01890437980797Easy FlushSPM MEDICARE PRIVATE LIMITEDNGT2026-03-07
18904379808009Easy FlushSPM MEDICARE PRIVATE LIMITEDNGT2026-03-07
00850063139472Neil Medical Group Neil Medical GroupNGT2025-12-08
00810192690053CerosRhino Medical Supply IncNGT2025-11-18
00810192690084CerosRhino Medical Supply IncNGT2025-11-18
00810192690121CerosRhino Medical Supply IncNGT2025-11-18
00810192690626CerosRhino Medical Supply IncNGT2025-11-18
30704411017619AMSafe® Pre-Filled Normal Saline Flush SyringeAMSINO INTERNATIONAL, INC.NGT2025-06-23
30704411017701AMSafe® Pre-Filled Normal Saline Flush SyringeAMSINO INTERNATIONAL, INC.NGT2025-06-23
30704411017718AMSafe® Pre-Filled Normal Saline Flush SyringeAMSINO INTERNATIONAL, INC.NGT2025-06-23
06971564461108GBUKJiangsu Caina Medical Co.,LtdNGT2025-05-14
06971564461115GBUKJiangsu Caina Medical Co.,LtdNGT2025-05-14
16971564461129GBUKJiangsu Caina Medical Co.,LtdNGT2025-05-14
16971564461136GBUKJiangsu Caina Medical Co.,LtdNGT2025-05-14
06971564462976GBUKJiangsu Caina Medical Co.,LtdNGT2025-05-14
16971564464564ITL BiomedicalJiangsu Caina Medical Co.,LtdNGT2025-05-14
16971564464571ITL BiomedicalJiangsu Caina Medical Co.,LtdNGT2025-05-14
20612479273157McKessonMCKESSON MEDICAL-SURGICAL INC.NGT2024-08-14
20612479273188McKessonMCKESSON MEDICAL-SURGICAL INC.NGT2024-08-14
20682686005285Praxiject™ SP 0.9% NaClMedxl IncNGT2024-07-25
10850421008928NURSE ASSISTNURSE ASSIST, INC.NGT2024-07-10
10850060997492CerosRhino Medical Supply IncNGT2024-03-18
10850060997508CerosRhino Medical Supply IncNGT2024-03-18
10850060997515CerosRhino Medical Supply IncNGT2024-03-18
10850060997522CerosRhino Medical Supply IncNGT2024-03-18
10386120013098RELI®MYCO MEDICAL SUPPLIES INC.NGT2024-03-12