FDA.reportPublic FDA data

Monoject

Primary DI
10884521010949
Brand
Monoject
Company
Cardinal Health, Inc.
Model
8881160157
Catalog number
8881160157
Device description
60 mL Syringe,Catheter 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
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMFSyringe, piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521010949PackageGS1100In Commercial Distribution
20884521010946PrimaryGS10
30884521010943Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452101094910884521010949
2088452101094620884521010946
3088452101094330884521010943

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 Volume3Milliliter
Total Volume6Milliliter
Total Volume12Milliliter
Total Volume18Gallon
Total Volume20Milliliter
Total Volume35Milliliter
Total Volume60Milliliter
Total Volume140Milliliter

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
20
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
false
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
10884521015920Dover20512C20512C2016-09-24
10884521015982Dover20520C20520C2016-09-24
10884521016002Dover20522C20522C2016-10-13
10884521024991Kendall924092402018-06-27
10884521025004Kendall924292422018-06-27
10884521025011Kendall924392432018-06-27
10884521025028Kendall924492442018-06-27
20192253002062Curity21462146-2018-12-12
20884521143064Magellan888183351588818335152016-09-24
10884527007110Argyle888816305588881630552016-09-24
10885380173691Curity6309G6309G2019-11-14
20885380173544Curity9022G9022G2019-11-14
20885380173568Curity9024G9024G2019-11-14
10884521141148Filac5040835040832016-09-24
10884521165045Kangaroo3881063881062016-09-24
10884521000674Dover35313531-2016-09-24
10884521001046Dover625562552016-09-24
10884521001138Dover825682562016-09-24
10884521001145Dover7016727016722016-09-24
10884521001206Dover7004ICLL7004ICLL2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10840330704868ProCureTwin Med, LLCFMF2026-05-27
10840330704875ProCureTwin Med, LLCFMF2026-05-27
08800052609303"Sure Fine Insulin Syringe 0.3cc 31G x 1/4"""SHINA MED CORPORATIONFMF2026-03-25
08800052609310"Sure Fine Insulin Syringe 0.3cc 31G x 5/16"""SHINA MED CORPORATIONFMF2026-03-25
08800052609327"Sure Fine Insulin Syringe 0.3cc 30g x 5/16"""SHINA MED CORPORATIONFMF2026-03-25
08800052609334"Sure Fine Insulin Syringe 0.3cc 30G x 1/2"""SHINA MED CORPORATIONFMF2026-03-25
08800052609341"Sure Fine Insulin Syringe 0.5cc 31G x 5/16"""SHINA MED CORPORATIONFMF2026-03-25
08800052609358"Sure Fine Insulin Syringe 0.5cc 30G x 1/2"""SHINA MED CORPORATIONFMF2026-03-25
08800052609365"Sure Fine Insulin Syringe 0.5cc 30G x 5/16"""SHINA MED CORPORATIONFMF2026-03-25
08800052609372"Sure Fine Insulin Syringe 0.5cc 29G x 1/2"""SHINA MED CORPORATIONFMF2026-03-25
08800052609389"Sure Fine Insulin Syringe 1.0cc 31G x 5/16"""SHINA MED CORPORATIONFMF2026-03-25
08800052609396"Sure Fine Insulin Syringe 1.0cc 30g x 5/16"""SHINA MED CORPORATIONFMF2026-03-25
08800052609402"Sure Fine Insulin Syringe 1.0cc 30G x 1/2"""SHINA MED CORPORATIONFMF2026-03-25
08800052609419"Sure Fine Insulin Syringe 1.0cc 29G x 1/2"""SHINA MED CORPORATIONFMF2026-03-25
08800052609426"Sure Fine Insulin Syringe 0.3cc 31G x 1/4"""SHINA MED CORPORATIONFMF2026-03-25
08800052609433"Sure Fine Insulin Syringe 0.3cc 31G x 5/16"""SHINA MED CORPORATIONFMF2026-03-25
08800052609440"Sure Fine Insulin Syringe 0.3cc 30g x 5/16"""SHINA MED CORPORATIONFMF2026-03-25
08800052609457"Sure Fine Insulin Syringe 0.3cc 30G x 1/2"""SHINA MED CORPORATIONFMF2026-03-25
08800052609464"Sure Fine Insulin Syringe 0.5cc 31G x 5/16"""SHINA MED CORPORATIONFMF2026-03-25
08800052609471"Sure Fine Insulin Syringe 0.5cc 30G x 1/2"""SHINA MED CORPORATIONFMF2026-03-25
08800052609488"Sure Fine Insulin Syringe 0.5cc 30G x 5/16"""SHINA MED CORPORATIONFMF2026-03-25
08800052609495"Sure Fine Insulin Syringe 0.5cc 29G x 1/2"""SHINA MED CORPORATIONFMF2026-03-25
08800052609501"Sure Fine Insulin Syringe 1.0cc 31G x 5/16"""SHINA MED CORPORATIONFMF2026-03-25
08800052609518"Sure Fine Insulin Syringe 1.0cc 30g x 5/16"""SHINA MED CORPORATIONFMF2026-03-25
08800052609525"Sure Fine Insulin Syringe 1.0cc 30G x 1/2"""SHINA MED CORPORATIONFMF2026-03-25
08800052609532"Sure Fine Insulin Syringe 1.0cc 29G x 1/2"""SHINA MED CORPORATIONFMF2026-03-25
08699207302028Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
08699207305036Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
08699207310030Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
08699207311006Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17