FDA.reportPublic FDA data

Argyle

Primary DI
10884527006571
Brand
Argyle
Company
Cardinal Health, Inc.
Model
MI30002
Catalog number
MI30002
Device description
Hydrogel Temperature Probe Cover,Rectangular
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMTWARMER, INFANT RADIANT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMTWarmer, Infant RadiantGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K964401000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K964401000KENDALL-LTP DISPOSABLE TEMPERATURE PROBES (DTP1,DTP2,DTP3,DTP4)Ludlow Technical Products1997-02-06FMT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884527006578PackageGS1800In Commercial Distribution
10884527006571PrimaryGS10
30884527006575Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452700657820884527006578
1088452700657110884527006571
3088452700657530884527006575

GMDN Terms#

Term, Definition table
TermDefinition
Armboard, reusableA device designed to stabilize a patient's arm during an intervention or procedure typically to maintain the patency of an intravenous (IV) needle or an intravascular catheter. It is typically an elongated, flat surface of expanded polystyrene, wood, or artificial fibre board that is covered with a durable plastic or coating that can be easily cleaned. It may have a metal attachment so that it can be affixed to, e.g., an operating/examination table, a blood donor couch, or a chair, or it may be placed on a flat surface (e.g., on top of an operating/examination table). This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length1.25Inch
Width0.75Inch

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
80
Lot or batch
true
Expiration date on label
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048675641308Babyleo TN500Drägerwerk AG & Co. KGaAFMT2026-03-23
10889483587881AirLife™AirLife Finland OyFMT2025-03-26
10889483587904AirLife™AirLife Finland OyFMT2025-03-26
20889483587888AirLife™AirLife Finland OyFMT2025-03-26
20889483587901AirLife™AirLife Finland OyFMT2025-03-26
10889483587959AirLife™AirLife Finland OyFMT2025-03-26
04048675436607Babyleo TN500Drägerwerk AG & Co. KGaAFMT2024-03-09
00865648000313NuBorne Infant WarmerINTERNATIONAL BIOMEDICAL, LTD.FMT2023-06-20
04049098099042Babyroo TN300 Infant Radiant WarmerDRAEGER MEDICAL SYSTEMS, INC.FMT2023-06-08
00749756379205DeRoyalDEROYAL INDUSTRIES, INC.FMT2023-02-06
50749756379200DeRoyalDEROYAL INDUSTRIES, INC.FMT2023-02-06
00860007476310ATOM Medical USA, Disposable ProbeAtom Medical Usa, LLCFMT2022-02-08
00195278358363GIRAFFE PANDA DISPOSABLE SKIN TEMPERATUREDatex-Ohmeda, Inc.FMT2021-11-10
00749756772358DeRoyalDEROYAL INDUSTRIES, INC.FMT2021-07-12
30749756772359DeRoyalDEROYAL INDUSTRIES, INC.FMT2021-07-12
00749756927550DeRoyalDEROYAL INDUSTRIES, INC.FMT2021-05-07
00749756927567DeRoyalDEROYAL INDUSTRIES, INC.FMT2021-05-07
00749756927574DeRoyalDEROYAL INDUSTRIES, INC.FMT2021-05-07
00749756983983DeRoyalDEROYAL INDUSTRIES, INC.FMT2021-05-07
00749756995566DeRoyalDEROYAL INDUSTRIES, INC.FMT2021-05-07
50749756927555DeRoyalDEROYAL INDUSTRIES, INC.FMT2021-05-07
50749756927562DeRoyalDEROYAL INDUSTRIES, INC.FMT2021-05-07
50749756927579DeRoyalDEROYAL INDUSTRIES, INC.FMT2021-05-07
50749756983988DeRoyalDEROYAL INDUSTRIES, INC.FMT2021-05-07
50749756995561DeRoyalDEROYAL INDUSTRIES, INC.FMT2021-05-07
00749756372305DeRoyalDEROYAL INDUSTRIES, INC.FMT2021-03-22
50749756372300DeRoyalDEROYAL INDUSTRIES, INC.FMT2021-03-22
10190752181236Airlife™AirLife Finland OyFMT2021-03-09
10190752181199Airlife™AirLife Finland OyFMT2021-03-05
20190752181196Airlife™VYAIRE MEDICAL, INC.FMT2021-03-05