FDA.reportPublic FDA data

BED MAT TIER3-7X36X80-AIR/FOAM-PC COVER

Primary DI
00840828184861
Brand
BED MAT TIER3-7X36X80-AIR/FOAM-PC COVER
Company
CURBELL MEDICAL PRODUCTS, INC.
Model
BM3-73680-AF-PC
Catalog number
27249
Device description
BED MAT TIER3-7X36X80-AIR/FOAM-FLAT DECK-POLYCARBONATE COVER-CFR1633
Published
2021-12-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
IKYMattress, Flotation Therapy, Non-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKYMattress, Flotation Therapy, Non-PoweredGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840828184861PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840828184861008408281848618408281848610840828184861

GMDN Terms#

Term, Definition table
TermDefinition
Flame-resistant bed mattressA large, durable, fabric case filled with a resilient material designed to be placed on a bed mattress support platform to provide a comfortable surface on which an occupant can lie and rest/sleep; it is also designed to retard flames in case of fire. The device provides no special therapeutic effect.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18002357500mwinter@curbell.com

Regulatory Flags#

DUNS number
796452311
Device count
1
Premarket exempt
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840828197007GEN4 INTERACTIVE4X331E-0D50508309072026-08-18
00840828197014RESPONDER 5, INTERACTIVE5I4116U-101453A309302026-08-18
008408281968570103,SCC,10',RAULAND LABELED,UL,PVC-FREE370260308932026-07-23
00840828196864GEN4 DIRECT ACCESS4C331U-Z10501H308832026-07-23
00840828196871GEN4 INTERACTIVE415400N-0500018308842026-07-23
00840828196888US MATT PAD-UNI-CONNECT-18MO-10X15CSP-US-U10308902026-07-23
00840828196895PAD-CORDED,UNDER SEAT,10"X15",92" CORDCSP-US-C10-92308912026-07-23
00840828196901PAD WIRELESS, UNDER SEAT, 10"X15"CSP-US-W10308922026-07-23
00840828196710P4600 90°,S4600,1 FT,R6,PS BREAKAWAYJUP-4600-1308492026-07-08
008408281967274600,R6,BASIC,2 LT,DV370202308542026-07-08
008408281967344600,R6,ENH,2 LT,DV370250308562026-07-08
00840828196741RESPONDER 5, INTERACTIVE4D41BN-A64403A308682026-07-08
00840828196758GEN4 INTERACTIVE4U190E-010402A308202026-07-08
00840828196765RESPONDER 5, INTERACTIVE5I41PU-100001A308232026-07-08
00840828196772RESPONDER 5, INTERACTIVE5I41PU-100041A308262026-07-08
00840828196789GEN4 INTERACTIVE437370U-0103448308712026-07-08
00840828196796GEN4 INTERACTIVE437370U-0100448308722026-07-08
00840828196802GEN4 INTERACTIVE43719FU-0104008308732026-07-08
00840828196819GEN4 INTERACTIVE43719FU-0103008308742026-07-08
00840828196826GEN4 INTERACTIVE433430U-0103009308772026-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
H93352765Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2026-08-25
H93363822Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2026-08-25
00817012020229K-11KAP MEDICALIKY2026-08-21
00810055884414MATT 35X80 DELUXE STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884421MATT 35X80 ELITE 500-G LBS STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16
0081005588443835X80 ELITE-G 500 STR ZIP COV INC BAR,CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884445MATT 35X76 DELUXE STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884452MATT 42X80 DELUXE STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884469MATT 42X80 ELITE-G 500 LBS STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884476MATT 35X80 DELUXE SW STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884483MATT 35X80 ELITE-G SW 500 STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884490MATT 35X80 BASIC STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884506MATT 35X76 ELITE-G 500 LBS STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884513MATT 35X84 DELUXE STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
0081005588452035X84 ELITE-G 500 STR ZIP COV INC BAR,CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884537MATT 42X80 ELITE-G 600 LBS STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884544MATT 35X76 DELUXE SW STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884551MATT 36X80 DELUXE STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884568MATT 36X80 ELITE-G 500 LBS STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884575MATT 35X80 ELITE-G 600 LBS STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884582MATT 35X76 ELITE-G SW 500 STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884599MATT 35X84 ELITE-G 500 LBS STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884612MATT 42X80 ELITE-G SW 500 STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884636MATT 39X80 DELUXE STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884643MATT 42X80 DELUXE SW STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884674MATT 36X80 DELUXE SW STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884681MATT 42X84 ELITE-G 500 LBS STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884704MATT 42X84 DELUXE STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884711MATT 35X84 DELUXE SW STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
0081005588472836X80 ELITE-G 500 STR ZIP COV INC BAR,CAJOERNS HEALTHCARE, LLCIKY2026-08-16