FDA.reportPublic FDA data

Devon

Primary DI
10884527014743
Brand
Devon
Company
Cardinal Health, Inc.
Model
31144168
Catalog number
31144168
Device description
Sponge Counting Rack for I.V. Pole,Multi-Bag
Published
2018-06-23
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
20884527014740PackageGS12In Commercial Distribution
10884527014743PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452701474020884527014740
1088452701474310884527014743

GMDN Terms#

Term, Definition table
TermDefinition
Surgical sponge-counting rackA device in the form of a vertically-mounted rack intended to be used in the operating room (OR) to maintain the count of surgical sponges/swabs during a surgical procedure, typically to prevent these items from being inadvertently left in a patient. It is a rack/holder with hooks/pockets upon which soiled sponges/swabs may be arranged; it may be used in conjunction with an associated counting bag (not included). This is a reusable 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
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521015791Dover888762312588876231252016-09-24
10884521153219Monoject118606026511860602652016-09-24
10884527021932Uni-PatchEP84580EP845802016-09-24
20884521012216Monoject888153578888815357882016-09-24
20884521012254Monoject888156018288815601822016-09-24
20884521014159Monoject888151613588815161352016-10-13
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

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Primary DI, Brand, Company table
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00810050863476AeroSled Transport Deck (TD)LIFEPORT, LLCFOX2026-05-26
00761887005419PryorPRYOR PRODUCTSFOX2026-05-25
00761887005433PryorPRYOR PRODUCTSFOX2026-05-25
00761887005440Connected RockPRYOR PRODUCTSFOX2026-05-25
00761887005457CorCytePRYOR PRODUCTSFOX2026-05-25
00761887005426PryorPRYOR PRODUCTSFOX2026-05-21
00810050863445Patient Loading Utility System (PLUS)LIFEPORT, LLCFOX2026-05-15
00810050863452Patient Loading Utility System (PLUS)LIFEPORT, LLCFOX2026-05-15
00810050863414Pole MountLIFEPORT, LLCFOX2026-04-28
00810050863421Pole MountLIFEPORT, LLCFOX2026-04-28
B458205997000HVP CartThe Wells Johnson CompanyFOX2026-04-20
B458205998000Wells Johnson Hymen CartThe Wells Johnson CompanyFOX2026-04-20
00810050863407Load RampLIFEPORT, LLCFOX2026-04-17
09420012405890Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDFOX2026-04-08
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00810050863391Medical CabinetLIFEPORT, LLCFOX2026-04-07
04260217220158chapot® table System Siemens Artis zee / Q / Q.zenAmtrion GmbHFOX2026-03-30
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09420012405999Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDFOX2026-03-26
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09420012405913Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDFOX2026-03-23
09420012425805Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDFOX2026-03-18
09420012426871Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDFOX2026-03-18
09420012433961Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDFOX2026-03-18
04061162024637CIM med GmbHCIM med GmbHFOX2026-03-18
04061162042907CIM med GmbHCIM med GmbHFOX2026-03-18