FDA.reportPublic FDA data

COMFOR CERVICAL PILLOW COVER

Primary DI
00610570027286
Brand
COMFOR CERVICAL PILLOW COVER
Company
Bird & Cronin, LLC
Model
08148715
Published
2022-08-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
IQKOrthosis, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQKOrthosis, CervicalPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00610570027286PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00610570027286006105700272866105700272860610570027286

GMDN Terms#

Term, Definition table
TermDefinition
Cervical spine cushionA soft pillow or pad used to provide support and comfort to the user's neck, often during the treatment and/or prevention of musculoskeletal disorders or injuries. The device may be used to alleviate pressure on the neck and spinal cord while the user is sitting, lying, or standing. This device may function as a cushion under the neck when the user is supine, or it may be placed, even secured, around the user's neck to help support the head.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
045975349
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00610570187386BULB HOLDER081482202022-10-31
00610570176519CHAS CATH-MATE STRAP081482002022-08-30
00610570176526CATH-MATE II CATHETER STRAP081482142022-08-30
00610570176786CHAS II CATH-MATE STRAP081482012022-08-30
00610570187379"CATH-MATE II X-LONG STRAP 28"""081482132022-08-30
50610570189552PRODY DRAINAGE BULB HOLDER II081477202022-08-30
00610570142309CHAS CATH-MATE STRAP 2/PK500082002022-08-20
00610570145584BULB HOLDER KIT081482212022-08-20
00610570157839"9"" ABD W/DRAIN HLDR UP TO 45"""081482262022-08-20
00610570157846"9"" ABD W/DRAIN HLDR 46-62"""081482272022-08-20
00610570157853"9"" ABD W/DRAIN HLDR 55-72"""081482282022-08-20
00610570165285"6"" ABD W/DRAIN HLDR UP TO 60"""081482302022-08-20
00610570165889"12"" ABD W/DRAIN HLDR UP TO 45"""081482362022-08-20
00610570165902"12"" ABD W/DRAIN HLDR 46-62"""081482372022-08-20
00610570165919"12"" ABD W/DRAIN HLDR 55-72"""081482382022-08-20
00610570165926"12"" ABD W/DRAIN HLDR 72-96"""081482392022-08-20
00610570189564PRODY DRAINAGE BULB HOLDER II KIT081477212022-08-20
00610570189571"PRODY 9"" ABD II W/DRAIN HLDR UP TO 45"""081477262022-08-20
00610570189588"PRODY 9"" ABD II W/DRAIN HLDR 46-62"""081477272022-08-20
00610570189595"PRODY 9"" ABD II W/DRAIN HLDR 55-72"""081477282022-08-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850071315226TrendOrthofix US LLCIQK2026-04-25
00850071315233TrendOrthofix US LLCIQK2026-04-14
00749756879699DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879705DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879712DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879729DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879736DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879750DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879767DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879774DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879804DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879811DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879828DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879835DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879989DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879996DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756880008DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756880084DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756880091DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756880107DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756887601DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756887618DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756887625DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756887632DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756887649DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756887656DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756887687DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756887694DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756887700DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756887717DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02