FDA.reportPublic FDA data

PRODY BULB HOLDER

Primary DI
00610570115655
Brand
PRODY BULB HOLDER
Company
Bird & Cronin, LLC
Model
08148220
Published
2022-10-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
FSDBinder, Abdominal
KMOBinder, Elastic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSDBinder, AbdominalGeneral Hospital1
KMOBinder, ElasticGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00610570187386PrimaryGS10
00610570115655Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00610570187386006105701873866105701873860610570187386
00610570115655006105701156556105701156550610570115655

GMDN Terms#

Term, Definition table
TermDefinition
Wearable percutaneous catheter/tube holderA device designed to fix a percutaneous catheter, tube, and/or drain (e.g., IV, epidural, or drainage catheter, GI tube) to a patient's body without suturing; it may additionally be intended for holding a non-surgically-invasive tube (e.g., nasogastric tube) to the patient (universal holder). It is designed as an adhesive pad, strip, or bandage that will attach to the patient's skin, sometimes with the exposed side having an integrated fixation mechanism (e.g., Velcro hook/loop closure) or a mechanical closure, to hold the catheter/tube in place. It may include a transparent film portion intended for fixation site monitoring. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
045975349
Device count
48
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00749756880398DeRoyalDEROYAL INDUSTRIES, INC.FSD2026-04-02
00749756880404DeRoyalDEROYAL INDUSTRIES, INC.FSD2026-04-02
00749756880411DeRoyalDEROYAL INDUSTRIES, INC.FSD2026-04-02
00749756880428DeRoyalDEROYAL INDUSTRIES, INC.FSD2026-04-02
00749756880435DeRoyalDEROYAL INDUSTRIES, INC.FSD2026-04-02
00749756888417DeRoyalDEROYAL INDUSTRIES, INC.FSD2026-04-02
00749756888424DeRoyalDEROYAL INDUSTRIES, INC.FSD2026-04-02
00745129333737Chipsleeve Arm No Hand SM Long LT SIGVARIS INCKMO2026-01-09
00745129333744Chipsleeve Arm No Hand SM Long RT SIGVARIS INCKMO2026-01-09
00745129333751Chipsleeve Arm No Hand SM Reg LT SIGVARIS INCKMO2026-01-09
00745129333768Chipsleeve Arm No Hand SM Reg RT SIGVARIS INCKMO2026-01-09
00745129333775Chipsleeve Arm No Hand SM Short LT SIGVARIS INCKMO2026-01-09
00745129333782Chipsleeve Arm No Hand SM Short RT SIGVARIS INCKMO2026-01-09
00745129333799Chipsleeve Arm No Hand MD Long LT SIGVARIS INCKMO2026-01-09
00745129333805Chipsleeve Arm No Hand MD Long RT SIGVARIS INCKMO2026-01-09
00745129333812Chipsleeve Arm No Hand MD Reg LT SIGVARIS INCKMO2026-01-09
00745129333829Chipsleeve Arm No Hand MD Reg RT SIGVARIS INCKMO2026-01-09
00745129333836Chipsleeve Arm No Hand MD Short LT SIGVARIS INCKMO2026-01-09
00745129333843Chipsleeve Arm No Hand MD Short RT SIGVARIS INCKMO2026-01-09
00745129333850Chipsleeve Arm No Hand LG Long LT SIGVARIS INCKMO2026-01-09
00745129333867Chipsleeve Arm No Hand LG Long RT SIGVARIS INCKMO2026-01-09
00745129333874Chipsleeve Arm No Hand LG Reg LT SIGVARIS INCKMO2026-01-09
00745129333881Chipsleeve Arm No Hand LG Reg RT SIGVARIS INCKMO2026-01-09
00745129333898Chipsleeve Arm No Hand LG Short LT SIGVARIS INCKMO2026-01-09
00745129333904Chipsleeve Arm No Hand LG Short RT SIGVARIS INCKMO2026-01-09
00745129333911Chipsleeve Arm No Hand XL Long LT SIGVARIS INCKMO2026-01-09
00745129333928Chipsleeve Arm No Hand XL Long RT SIGVARIS INCKMO2026-01-09
00745129333935Chipsleeve Arm No Hand XL Reg LT SIGVARIS INCKMO2026-01-09
00745129333942Chipsleeve Arm No Hand XL Reg RTSIGVARIS INCKMO2026-01-09
00745129333959Chipsleeve Arm No Hand XL Short LT SIGVARIS INCKMO2026-01-09