FDA.report

SharpSafety

Primary DI
20884521023366
Brand
SharpSafety
Company
Cardinal Health, Inc.
Model
85221R
Catalog number
85221R
Device description
In Room Sharps Container,Always Open Lid, Transparent Red
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

Related Records

Contact Domains

Product Codes

CodeName
MMKContainer, sharps

Product Code Classifications

CodeDeviceSpecialtyClass
MMKContainer, SharpsGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20884521023366PackageGS110In Commercial Distribution
10884521023369PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2088452102336620884521023366
1088452102336910884521023369

GMDN Terms

TermDefinition
Sharps containerA hard-walled container designed for the safe deposit and collection of biologically or chemically contaminated used sharps; this includes needles, lancets, scalpel blades, cannulae, or other devices that present a hazard to a healthcare worker or patient if they were to inadvertently have bodily contact with the device and cause themselves an injury. This container is typically designed to be puncture resistant, leak-proof, and closable (usually having a lid that cannot be reopened once closed) and is identified with the universal biohazard symbol on its labelling. It is disposed of when filled to the recommended level, typically by incineration.

Device Sizes

TypeValueUnit
Total Volume3Gallon

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00;

Sterilization Methods

Method

Contacts

PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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20884527020529Argyle888816035888881603582016-09-28
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10884521000735Argyle888875051388887505132016-09-24
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10884521011526Kangaroo888474122088847412202016-10-20
10884521011533Kangaroo888474122588847412252016-09-24
10884521011557Kangaroo888474123588847412352016-09-24
10884521011595Kangaroo888474164988847416492016-09-24

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