FDA.reportPublic FDA data

TOTAL CARE RPL KIT , URETHANE, 36"X84

Primary DI
00840828162463
Brand
TOTAL CARE RPL KIT , URETHANE, 36"X84
Company
CURBELL MEDICAL PRODUCTS, INC.
Model
MCT-3684PN
Catalog number
9259
Device description
TOTAL CARE RPL KIT , URETHANE, 36"X84
Published
2018-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMWCover, Mattress (Medical Purposes)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMWCover, Mattress (Medical Purposes)General Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840828162463PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840828162463008408281624638408281624630840828162463

GMDN Terms#

Term, Definition table
TermDefinition
Probiotic bed mattress coverA device made of soft textile materials shaped to fit over a bed mattress, to protect the mattress and prevent cross-contamination, that is treated/impregnated with probiotic bacteria intended to consume the allergen-containing faecal droppings of house dust mites (HDM) to reduce the risk of patient allergic reactions. The device can be laundered for cleaning. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18002357500mwinter@curbell.com

Regulatory Flags#

DUNS number
796452311
Device count
1
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
00840828196178JUMPER,6",S102 TO 7 PIN DINJU06-626306542026-03-20
00840828187374SURE LOCK, ASSEMBLY, A34, BLUE LEVERSLC-4200-006277592023-01-09
00840828196109GEN4 PLUS, DIRECT ACCESS5C383U-Z10300008306042026-03-11
00840828196116GEN4 INTERACTIVE4G331E-0148798305822026-03-11
00840828196123RESPONDER 5, INTERACTIVE5I4112U-B64453A306142026-03-11
00840828196130RESPONDER 5, INTERACTIVE5I4112U-101471A306052026-03-11
00840828196147RESPONDER 5, INTERACTIVE5I4112U-500001A306082026-03-11
00840828196154RESPONDER 5, INTERACTIVE5I411U-F00001A306112026-03-11
00840828196161GEN4 INTERACTIVE414430U-0151049306152026-03-11
00840828196079GEN4 DIRECT ACCESS4C19NN-Z10200A305452026-03-04
00840828196086GEN4 DIRECT ACCESS4C19NN-Z10200C305462026-03-04
00840828196093RESPONDER 5, INTERACTIVE5I4112U-001462A306012026-03-04
00840828196000GEN4 INTERACTIVE43319FU-0143088305712026-03-03
00840828196017GEN4 INTERACTIVE4X331E-000503C305812026-03-03
00840828196024RESPONDER 5, INTERACTIVE5I41JU-363465A305862026-03-03
00840828196031GEN4 INTERACTIVE414370E-010346A305932026-03-03
00840828196048RESPONDER 5, INTERACTIVE5I41JU-363425A305942026-03-03
00840828196055GEN4 INTERACTIVE4M370E-Z749368305962026-03-03
00840828196062GEN4 INTERACTIVE4M370E-Z749448305982026-03-03
00840828195966ZEPHYR,800,10,PUFF,JERON 680GEB-19C0-203A-N305512026-02-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850045714581Soteria Mattress BarrierTrinity Guardion, Inc.FMW2026-03-10
00840828195898BED COVER-4X36X84-PROGRESSA PULM TOP-PCCURBELL MEDICAL PRODUCTS, INC.FMW2026-01-20
07640178061446CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178061736CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178061828CT Table CoverPearl Technology AGFMW2025-12-17
07640178061835CT Table CoverPearl Technology AGFMW2025-12-17
07640178061842CT Table CoverPearl Technology AGFMW2025-12-17
07640178061927CT Table CoverPearl Technology AGFMW2025-12-17
07640178061934CT Table CoverPearl Technology AGFMW2025-12-17
07640178061941CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178061958CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178061965CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178061972CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178061989CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178061996CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062009CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062016CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062023CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062030CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062047CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062054CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062061CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062184CT Table CoverPearl Technology AGFMW2025-12-17
07640178062191CT Table CoverPearl Technology AGFMW2025-12-17
07640178062207CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062214CT Table CoverPearl Technology AGFMW2025-12-17
00850045714536Soteria Neonatal Mattress BarrierTrinity Guardion, Inc.FMW2025-08-18
00840828194433BED COVER 8X36X86 P500 VC STEP DECK - PCCURBELL MEDICAL PRODUCTS, INC.FMW2025-08-11
00818323020403SuresVIVE HEALTH LLCFMW2025-07-09
00818323020410SuresVIVE HEALTH LLCFMW2025-07-09