FDA.reportPublic FDA data

DuoGard

Primary DI
57613327282288
Brand
DuoGard
Company
STRYKER CORPORATION
Model
2780-300-000
Catalog number
2780-300-000
Published
2016-09-24
Public version status
Update
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
IOQBED, FLOTATION THERAPY, POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IOQBed, Flotation Therapy, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
57613327282288PackageGS16In Commercial Distribution
07613327282283PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5761332728228857613327282288
07613327282283076133272822837613327282283

GMDN Terms#

Term, Definition table
TermDefinition
Air-filled bed mattress overlayA static-air-inflated pad or thin mattress, usually full-body length, which is placed on top of a bed mattress to distribute an occupant's body weight over a large surface area, typically to relieve pressure points for comfort and to prevent pressure sores. It is commonly used for elderly immobilized (especially in cases of decubitus ulcers), patients with disabilities, or patients with low body fat. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078470558
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
07613327687637N/A65170400166517-040-0162026-03-19
07613327687644N/A65170400106517-040-0102026-03-19
07613327687651N/A65170700216517-070-0212026-03-19
07613327687668N/A65170480216517-048-0212026-03-19
07613327687675N/A65170400126517-040-0122026-03-19
07613327628357RPS88080000008808-000-0002025-10-01
07613327656763BPX79000120007900-012-0002026-03-04
07613327656770BPX79000130007900-013-0002026-03-04
07613327657760BPX79000340007900-034-0002026-03-04
07613327657777BPX79000150007900-015-0002026-03-04
07613327657784BPX79000310007900-031-0002026-03-04
07613327657791BPX79000990007900-099-0002026-03-04
07613327657807N/A79003760107900-376-0102026-03-04
07613327657814BPX79000370007900-037-0002026-03-04
07613327657821N/A79003770107900-377-0102026-03-04
07613327657838N/A79003780107900-378-0102026-03-04
07613327659429BPX79000250007900-025-0002026-03-04
37613327693288Malis6760-180-0106760-180-010-Z012026-02-25
37613327693295Malis6760-180-0056760-180-005-Z012026-02-25
37613327693363Malis6760-180-0156760-180-015-Z012026-02-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08592654562703Multicare XL I N E T spol. s r.o.IOQ2026-01-07
08592654550441MulticareL I N E T spol. s r.o.IOQ2025-12-22
08592654510407MulticareL I N E T spol. s r.o.IOQ2025-05-26
00817012031669K-3 AIRE-ZONEKAP MEDICALIOQ2025-04-04
M368LS900361LUMEXGF HEALTH PRODUCTS, INC.IOQ2025-03-01
M368LS900421LUMEXGF HEALTH PRODUCTS, INC.IOQ2025-03-01
M368LS900481LUMEXGF HEALTH PRODUCTS, INC.IOQ2025-03-01
M368LS900MAT361LUMEXGF HEALTH PRODUCTS, INC.IOQ2025-03-01
M368LS900MAT421LUMEXGF HEALTH PRODUCTS, INC.IOQ2025-03-01
M368LS900MAT481LUMEXGF HEALTH PRODUCTS, INC.IOQ2025-03-01
M369LS900P1LUMEXGF HEALTH PRODUCTS, INC.IOQ2025-03-01
00887761007710Centrella™ SurfaceHILL-ROM, INC.IOQ2024-11-27
00887761007727Centrella™ SurfaceHILL-ROM, INC.IOQ2024-11-27
00887761007734Centrella™ SurfaceHILL-ROM, INC.IOQ2024-11-27
00887761007741Centrella™ SurfaceHILL-ROM, INC.IOQ2024-11-27
00887761007758Centrella™ SurfaceHILL-ROM, INC.IOQ2024-11-27
00887761007765Centrella™ SurfaceHILL-ROM, INC.IOQ2024-11-27
08592654466933Multicare XL I N E T spol. s r.o.IOQ2024-10-23
00887761966819Centrella™ SurfaceHILL-ROM, INC.IOQ2024-09-20
10670482000774oneNEST MUmano Medical IncIOQ2024-06-21
06977071938102MeicenGuangdong Meicen Medical Equipment Co., Ltd.IOQ2024-06-21
04719873696901NACARILEX MEDICAL, INC.IOQ2024-06-20
14719873696915NACARILEX MEDICAL, INC.IOQ2024-06-20
04719873696925NACARILEX MEDICAL, INC.IOQ2024-06-20
14719873696939NACARILEX MEDICAL, INC.IOQ2024-06-20
00817012031485K-3oem EZ-AIREKAP MEDICALIOQ2024-06-14
10670482000781oneNEST MUmano Medical IncIOQ2024-06-07
10670482000798oneNEST M Control unit Umano Medical IncIOQ2024-06-07
10670482000804oneNEST M Control unitUmano Medical IncIOQ2024-06-07
00887761967182Progressa+ surfaceHill-Rom de México, S. de R.L. de C.V.IOQ2024-05-31