FDA.reportPublic FDA data

Monoject

Primary DI
30884521027651
Brand
Monoject
Company
Cardinal Health, Inc.
Model
8881682135
Catalog number
8881682135
Device description
Syringe Tip Caps
Published
2018-06-27
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

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
30884521027651PackageGS112000In Commercial Distribution
20884521027654PrimaryGS10
40884521027658Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3088452102765130884521027651
2088452102765420884521027654
4088452102765840884521027658

GMDN Terms#

Term, Definition table
TermDefinition
Syringe tip capA device intended to cover the tip of a syringe (without a needle) in order to prevent the leakage of syringe contents and to maintain content sterility until the syringe is used. This device is typically constructed of plastic. This is a single-use device.

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
25
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
10809160500040Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.KDC2025-10-28
10198459343520MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KDC2025-05-22
10192253052404DevonCardinal Health 200, LLCKDC2025-03-27
10653160385769MEDLINEMEDLINE INDUSTRIES, INC.KDC2025-01-29
10653160383208CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKDC2024-12-03
10653160383123MEDLINEMEDLINE INDUSTRIES, INC.KDC2024-11-21
10653160383130MEDLINEMEDLINE INDUSTRIES, INC.KDC2024-11-21
10653160383147MEDLINEMEDLINE INDUSTRIES, INC.KDC2024-11-21
10653160382119MEDLINEMEDLINE INDUSTRIES, INC.KDC2024-11-04
10653160381501MEDLINEMEDLINE INDUSTRIES, INC.KDC2024-10-18
10653160381228MEDLINEMEDLINE INDUSTRIES, INC.KDC2024-10-11
10653160381334MEDLINEMEDLINE INDUSTRIES, INC.KDC2024-10-11
10653160379874CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKDC2024-09-11
10653160379232MEDLINEMEDLINE INDUSTRIES, INC.KDC2024-08-28
10653160375128MEDLINEMEDLINE INDUSTRIES, INC.KDC2024-05-28
10653160375340MEDLINEMEDLINE INDUSTRIES, INC.KDC2024-05-28
10653160374183CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKDC2024-05-02
10653160369592CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKDC2023-12-18
10653160369462CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKDC2023-12-11
10653160369431CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKDC2023-12-08
10653160369448CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKDC2023-12-08
10653160365815CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKDC2023-09-05
10080196415472MedlineMEDLINE INDUSTRIES, INC.KDC2023-06-22
10705031470507MERSILENEETHICON, LLCKDC2023-05-30
10653160360766CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKDC2023-05-29
10653160359197CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKDC2023-03-17
10810102270921Dermapac, Inc.Dermapac Inc.KDC2022-09-12
10810102270938Dermapac, Inc.Dermapac Inc.KDC2022-09-12
10810102270945Dermapac, Inc.Dermapac Inc.KDC2022-09-12
10810102270952Dermapac, Inc.Dermapac Inc.KDC2022-09-12