FDA.report

BED MAT TIER2-6X35X80-3LYR FOAM-PC

Primary DI
00840828191128
Brand
BED MAT TIER2-6X35X80-3LYR FOAM-PC
Company
CURBELL MEDICAL PRODUCTS, INC.
Model
BM2-63680-3LF-PC
Catalog number
29006
Device description
BED MAT TIER2-6X35X80-3 LAYER FOAM-FLAT DECK-POLYCARBONATE COVER
Published
2024-05-23
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
false

Related Records

Contact Domains

Product Codes

CodeName
IKYMattress, Flotation Therapy, Non-Powered

Product Code Classifications

CodeDeviceSpecialtyClass
IKYMattress, Flotation Therapy, Non-PoweredGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840828191128PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840828191128008408281911288408281911280840828191128

GMDN Terms

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

Contacts

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
false
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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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

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