FDA.reportPublic FDA data

Argyle

Primary DI
20192253045304
Brand
Argyle
Company
Cardinal Health 200, LLC
Model
30953130
Catalog number
30953130
Device description
ArgyleTM Baby BeaniesSingle Ply, Pink/Blue Stripes
Published
2022-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
FSDBINDER, ABDOMINAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSDBinder, AbdominalGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50192253045305PackageGS19In Commercial Distribution
20192253045304PrimaryGS10
10192253045307Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019225304530550192253045305
2019225304530420192253045304
1019225304530710192253045307

GMDN Terms#

Term, Definition table
TermDefinition
Abdominal binder, single-useA strip, roll or tube of fabric or polymer material intended to be applied to the abdomen to support relaxed abdominal walls (e.g., after surgery, during pregnancy) or to provide support for another device (e.g., dressing, ultrasound transducer, percutaneous lead). This is a single-use device.

Regulatory Flags#

DUNS number
961027315
Device count
50
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253033502Monoject118030055511803005552022-10-21
10630140029332CONVERTORS29459294592016-06-28
10630140031403CONVERTORS29461294612016-06-28
10885380026577CONVERTORS29435294352016-06-28
10885380034862CONVERTORS74210742102016-06-28
10885380038075CONVERTORS29520295202016-06-28
10885380053740CONVERTORS29456294562016-06-22
10885380058134CONVERTORSD1062D10622016-06-29
10885380058387CONVERTORS945094502016-06-28
10885380062278CONVERTORS944494442016-06-22
10885380062285CONVERTORS755475542016-06-28
10885380062308CONVERTORS955695562016-07-08
10885380063664CONVERTORS29452294522016-06-28
10885380071539CONVERTORS956295622016-07-13
10885380071652CONVERTORS29417294172016-06-28
10885380071690CONVERTORS29458294582016-06-28
10885380108624CONVERTORS29430294302016-06-22
10885380108648CONVERTORS29447294472016-06-22
10885380108655CONVERTORS29448294482016-06-22
10885380108662CONVERTORS29449294492016-06-22

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Primary DI, Brand, Company table
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00749756880435DeRoyalDEROYAL INDUSTRIES, INC.FSD2026-04-02
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00749756888424DeRoyalDEROYAL INDUSTRIES, INC.FSD2026-04-02
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