FDA.reportPublic FDA data

SharpSafety

Primary DI
10884521067806
Brand
SharpSafety
Company
Cardinal Health, Inc.
Model
88361H
Catalog number
88361H
Device description
Wall Enclosure,For Pharmaceutical Waste Container
Published
2018-06-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FOXSTAND, INFUSION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FOXStand, InfusionGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521067806PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452106780610884521067806

GMDN Terms#

Term, Definition table
TermDefinition
Cytotoxic waste containerA container made of metal, hard plastic and/or cardboard designed for the safe deposit, collection and storage of cytotoxic materials (e.g., chemotherapy/antineoplastic drugs). It is typically used with a liner or a sealed leak proof bag, and has a lid for that allows temporary and final closure options; the lid typically includes a seal to prevent leakage. It is identified with a cytotoxic biohazard symbol on its labelling and sent to an appropriate waste treatment plant for disposal when filled to the recommended level.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume3Gallon

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00;

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
080935429
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521190948Kangaroo384500W384500W2017-09-12
10884521190894Kangaroo3844003844002017-08-02
10884521544475Wings67093670932018-06-27
20884521544489Wings67095670952018-06-27
10884521023284Monoject8507SA8507SA2016-09-24
10884521208742Devon31145892311458922018-06-29
20884521154244Monoject8985PG2Y8985PG2Y2017-01-06
20884521513423Kendall8618RC8618RC2017-05-27
20884521706177Kangaroo388105E388105E2017-04-20
20884527016034Devon31145926311459262018-06-29
30884521022533Monoject8997SPG28997SPG22016-09-24
30884521022557Monoject8998SPG28998SPG22016-09-24
30884527016048Devon31145942311459422018-06-29
40884521022417Monoject8932PG28932PG22016-09-24
10884521019119SharpSafety8556H8556H2018-06-27
20884527000125Argyle888825737888882573782016-09-24
20884527000132Argyle888825738688882573862016-09-24
10884527019854Argyle888850103188885010312016-09-24
10884527019922Argyle888850200588885020052016-09-24
10884527019847Argyle888850102388885010232016-09-24

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Primary DI, Brand, Company table
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00628678604179O2 Mount PS5000Technimount Medicale IncFOX2026-09-21
00628678604186Bracket Pro Serie® 26 – FQTechnimount Medicale IncFOX2026-09-21
00628678604193CARDIATEK®Technimount Medicale IncFOX2026-09-21
00810050863612Patient Loading Utility System (PLUS)LIFEPORT, LLCFOX2026-09-21
00628678604087ContinuuMed™ RIVTechnimount Medicale IncFOX2026-09-18
00628678604094ContinuuMed™ PVTTechnimount Medicale IncFOX2026-09-18
00628678604100Standard Surface BaseTechnimount Medicale IncFOX2026-09-18
00628678604117Universal BaseTechnimount Medicale IncFOX2026-09-18
00810050863544Arch InstallationLIFEPORT, LLCFOX2026-08-25
00810050863551IV PoleLIFEPORT, LLCFOX2026-08-25
00810050863568Arch InstallationLIFEPORT, LLCFOX2026-08-25
00810050863575Arch AssemblyLIFEPORT, LLCFOX2026-08-25
00810050863506Medical CabinetLIFEPORT, LLCFOX2026-08-03
00841027105695Pedigo Products, Inc.PEDIGO PRODUCTS, INC.FOX2026-06-26
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04061162002116CIM med GmbHCIM med GmbHFOX2026-05-31
04061162051893CIM med GmbHCIM med GmbHFOX2026-05-31
00885403530145TRUCLIPBecton, Dickinson And CompanyFOX2026-05-30
00840432200056Verathon®Verathon Medical (Canada) ULCFOX2026-05-28
00761887005426PryorPRYOR PRODUCTSFOX2026-05-21
00810050863445Patient Loading Utility System (PLUS)LIFEPORT, LLCFOX2026-05-15
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