FDA.reportPublic FDA data

36X84 ELITE-G 500 STR ZIP COV INC BAR,CA

Primary DI
00810055884766
Brand
36X84 ELITE-G 500 STR ZIP COV INC BAR,CA
Company
JOERNS HEALTHCARE, LLC
Model
PEGF3684SZP500CA
Device description
36X84 ELITE-G 500 STR ZIP COV INC BAR,CA
Published
2026-08-16
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

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
00810055884766PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810055884766008100558847668100558847660810055884766

GMDN Terms#

Term, Definition table
TermDefinition
Foam bed mattressA large, durable, fabric case filled with foam, which may be segmented/compartmentalised, designed to be placed on a bed mattress support platform to provide a comfortable surface on which an occupant can lie, rest, and sleep, and intended to distribute body weight over a large surface area typically to help relieve pressure points for comfort and improve blood circulation to prevent pressure sores. It may contain weight-distribution air cells. This is a reusable device.

Regulatory Flags#

DUNS number
790937150
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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
00810055883028JOERNS HOY UP STANDAID, 440LBSHOY-UP2026-08-15
00810055884414MATT 35X80 DELUXE STR ZIP COV CAPDF3580SZ500CA2026-08-16
00810055884421MATT 35X80 ELITE 500-G LBS STR ZIP COV CPEGF3580SZ500CA2026-08-16
0081005588443835X80 ELITE-G 500 STR ZIP COV INC BAR,CAPEGF3580SZP500CA2026-08-16
00810055884445MATT 35X76 DELUXE STR ZIP COV CAPDF3576SZ500CA2026-08-16
00810055884452MATT 42X80 DELUXE STR ZIP COV CAPDF4280SZ500CA2026-08-16
00810055884469MATT 42X80 ELITE-G 500 LBS STR ZIP COV CPEGF4280SZ500CA2026-08-16
00810055884476MATT 35X80 DELUXE SW STR ZIP COV CAPDS3580SZ500CA2026-08-16
00810055884483MATT 35X80 ELITE-G SW 500 STR ZIP COV CPEGS3580SZ500CA2026-08-16
00810055884490MATT 35X80 BASIC STR ZIP COV CAPBF3580SZ500CA2026-08-16
00810055884506MATT 35X76 ELITE-G 500 LBS STR ZIP COV CPEGF3576SZ500CA2026-08-16
00810055884513MATT 35X84 DELUXE STR ZIP COV CAPDF3584SZ500CA2026-08-16
0081005588452035X84 ELITE-G 500 STR ZIP COV INC BAR,CAPEGF3584SZP500CA2026-08-16
00810055884537MATT 42X80 ELITE-G 600 LBS STR ZIP COV CPEGF4280SZ600CA2026-08-16
00810055884544MATT 35X76 DELUXE SW STR ZIP COV CAPDS3576SZ500CA2026-08-16
00810055884551MATT 36X80 DELUXE STR ZIP COV CAPDF3680SZ500CA2026-08-16
00810055884568MATT 36X80 ELITE-G 500 LBS STR ZIP COV CPEGF3680SZ500CA2026-08-16
00810055884575MATT 35X80 ELITE-G 600 LBS STR ZIP COV CPEGF3580SZ600CA2026-08-16
00810055884582MATT 35X76 ELITE-G SW 500 STR ZIP COV CPEGS3576SZ500CA2026-08-16
00810055884599MATT 35X84 ELITE-G 500 LBS STR ZIP COV CPEGF3584SZ500CA2026-08-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00810055884735MATT 35X84 ELITE-G SW 500 STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884742MATT 42X84 ELITE-G 600 LBS STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884759MATT 39X80 ELITE-G 500 LBS STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16