FDA.reportPublic FDA data

Argyle

Primary DI
10884527020034
Brand
Argyle
Company
Cardinal Health, Inc.
Model
MI00625
Catalog number
MI00625
Device description
Phototherapy Eye Protector,Large
Published
2018-06-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FOKPAD, NEONATAL EYE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FOKPad, Neonatal EyeGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884527020031PackageGS150In Commercial Distribution
10884527020034PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452702003120884527020031
1088452702003410884527020034

GMDN Terms#

Term, Definition table
TermDefinition
Eye padA cushion-like device made of various materials (e.g., gauze, cotton) intended to protect the eye or to absorb eye secretions. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length5.5Inch
Width1.5Inch

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
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884527019854Argyle888850103188885010312016-09-24
10884527019922Argyle888850200588885020052016-09-24
10884527019847Argyle888850102388885010232016-09-24
30884527016048Devon31145942311459422018-06-29
10884521170728Kendall507250722016-09-24
10884527023240Kerlix258525852018-06-23
10884527023295Kerlix507250722018-06-30
10884521744585Kendall8608U8608U2017-09-07
10884521744608Kendall8617U8617U2017-09-07
10884521744622Kendall8618U8618U2017-09-07
20884521100432SharpSafety8608U8608U2016-09-24
20884521100463Monoject8617U8617U2016-09-24
20884521100470Monoject8618U8618U2016-09-24
40884521023100Monoject31142222311422222016-09-24
10884521020511Monoject888124713788812471372018-06-30
20884527000088Argyle888472450488847245042018-06-30
00884521144227Webcol16818168182018-06-22
10884521189652Monoject1186000444T1186000444T2016-09-24
10884527007110Argyle888816305588881630552016-09-24
20885380173537Curity7267G7267G2019-11-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05713315011764BilibandNatus Medical Denmark ApSFOK2025-10-14
05713315011771BilbandNatus Medical Denmark ApSFOK2025-10-14
05713315011788BilibandNatus Medical Denmark ApSFOK2025-10-14
00850018561273WeeSpecs Infant Eye ProtectionINTERNATIONAL BIOMEDICAL, LTD.FOK2023-06-21
00817770020561EyeMax2MAXTEC, LLCFOK2023-06-12
00817770025818EyeMax2MAXTEC, LLCFOK2023-06-12
00817770025825EyeMax2MAXTEC, LLCFOK2023-06-12
00817770025832EyeMax2MAXTEC, LLCFOK2023-06-12
10190676001931POSEYPOSEY PRODUCTS, LLCFOK2022-10-06
10190676001948POSEYPOSEY PRODUCTS, LLCFOK2022-10-06
20190676001938POSEYPOSEY PRODUCTS, LLCFOK2022-10-06
20190676001945POSEYPOSEY PRODUCTS, LLCFOK2022-10-06
10190676001924POSEY EYE PROTECTORSPOSEY PRODUCTS, LLCFOK2022-08-04
00190676001927POSEY EYE PROTECTORSPOSEY PRODUCTS, LLCFOK2022-08-04
00817770022411EyeMax2MAXTEC, LLCFOK2021-10-25
00749756139588DeRoyalDEROYAL INDUSTRIES, INC.FOK2021-07-12
00749756139595DeRoyalDEROYAL INDUSTRIES, INC.FOK2021-07-12
00749756139601DeRoyalDEROYAL INDUSTRIES, INC.FOK2021-07-12
00749756139618DeRoyalDEROYAL INDUSTRIES, INC.FOK2021-07-12
00749756139625DeRoyalDEROYAL INDUSTRIES, INC.FOK2021-07-12
00749756173872DeRoyalDEROYAL INDUSTRIES, INC.FOK2021-07-12
00749756562515DeRoyalDEROYAL INDUSTRIES, INC.FOK2021-07-12
00749756562522DeRoyalDEROYAL INDUSTRIES, INC.FOK2021-07-12
50749756139583DeRoyalDEROYAL INDUSTRIES, INC.FOK2021-07-12
50749756139590DeRoyalDEROYAL INDUSTRIES, INC.FOK2021-07-12
50749756139606DeRoyalDEROYAL INDUSTRIES, INC.FOK2021-07-12
50749756139613DeRoyalDEROYAL INDUSTRIES, INC.FOK2021-07-12
50749756139620DeRoyalDEROYAL INDUSTRIES, INC.FOK2021-07-12
50749756173877DeRoyalDEROYAL INDUSTRIES, INC.FOK2021-07-12
50749756562510DeRoyalDEROYAL INDUSTRIES, INC.FOK2021-07-12