FDA.reportPublic FDA data

Monoject

Primary DI
10884527023646
Brand
Monoject
Company
Cardinal Health, Inc.
Model
8881682150
Catalog number
8881682150
Device description
Tip Cap,Luer-Slip or Luer-Lock Syringes, Blue
Published
2018-06-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
20884527023643PackageGS112000In Commercial Distribution
10884527023646PrimaryGS10
30884527023640Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452702364320884527023643
1088452702364610884527023646
3088452702364030884527023640

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

Contacts#

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

Regulatory Flags#

DUNS number
080935429
Device count
25
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521156159Monoject8934CRS8934CRS2017-01-06
10884521156173Monoject8985CRH8985CRH2017-01-07
20884521156200Monoject8985CRS8985CRS2017-01-07
20884521156217Monoject8989CRH8989CRH2017-01-07
10884521010444Monoject888147127388814712732018-06-30
10884521157682Curity2022A2022A2018-06-22
10884521195547Monoject1180327114E1180327114E2018-06-22
20884521195506Monoject1180323114E1180323114E2018-06-22
40884521010438Monoject888147123288814712322018-06-30
40884521018311SharpSafety8535Y8535Y2017-01-07
40884521018380Monoject8970Y8970Y2017-01-06
10884521742390Monoject888135278888813527882019-05-17
10884527006786Monoject888135278888813527882016-09-24
10884521131897VistecVS4332VS43322018-06-30
30884527004755Kendall50007363500073632016-09-24
10884521028258Kangaroo6746696746692019-11-27
10884521069343Dover888766526288876652622016-10-20
10884527010349KendallMK06860MK068602016-09-24
10884527022113Kendall3353433534-2016-09-24
10885380173691Curity6309G6309G2019-11-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00749756402545DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402552DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402569DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402576DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402583DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402590DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402606DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402613DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402620DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402637DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402644DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402651DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402675DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402682DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402712DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402729DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402736DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402743DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402774DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402538DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-06-26
05060212051721Clamp Cover Red (Small) 50mmDTR MEDICAL LIMITEDKDC2026-06-10
05060212051738Clamp Cover White (Med) 120mmDTR MEDICAL LIMITEDKDC2026-06-10
05060212051745Clamp Cover Blue (Large) 120mmDTR MEDICAL LIMITEDKDC2026-06-10
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