FDA.reportPublic FDA data

Isolibrium

Primary DI
07613327390049
Brand
Isolibrium
Company
STRYKER CORPORATION
Model
2972
Catalog number
297205550001
Published
2017-08-11
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IKZBED, PATIENT ROTATION, POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKZBed, Patient Rotation, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327390049PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327390049076133273900497613327390049

GMDN Terms#

Term, Definition table
TermDefinition
Flotation therapy bed, adultA mains electricity (AC-powered) bed designed to minimize pressure points on a patient's body by providing contact with as much of the body surface as possible, typically through a mattress that contains a large volume of constantly moving media, e.g., water, air, or mud that lifts the patient to simulate a floating effect. It is used in cases of decubitus ulcers or where a patient has little remaining body fat and the displacement of body weight is vital for treatment and/or comfort. It can also be used for the treatment badly burned patients and/or to aid circulation. The device may allow for the regulation of mattress temperature to enhance treatment.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature-40 Degrees Fahrenheit140 Degrees Fahrenheit
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
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
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613252450337ICONIX3910-500-5123910-500-5122015-08-26
07613252450344ICONIX3910-500-5223910-500-5222015-08-26
07613252450351ICONIX3910-500-5253910-500-5252015-08-26
07613252450368ICONIX3910-500-5323910-500-5322015-08-26
07613327176926ICONIX39105003123910-500-3122015-09-14
07613327176933ICONIX39105003223910-500-3222015-09-14
07613327283440ICONIX39105002123910-500-2122016-09-22
07613327298642Sonopet iQ55000083005500-008-3002019-05-03
07613327056952SERFAS Energy0279351100279-351-1002016-09-23
07613327056976SERFAS Energy0279351103279-351-1032016-09-23
07613327057027SERFAS Energy0279401100279-401-1002016-09-23
07613327057034SERFAS Energy02794012000279-401-2002016-09-23
07613327057041SERFAS Energy02793514000279-351-4002016-09-23
07613327058048CrossFlow045000000004500000002016-09-23
07613327294606NanoTackCAT02969CAT029692016-07-20
07613327643800NA79000620007900-062-0002025-12-19
07613327643824NA79001260007900-126-0002025-12-19
07613327643848NA79001250007900-125-0002025-12-19
00897146002025Adherus NUS-109NUS-1092016-12-19
00897146002018Adherus NUS-106NUS-1062015-04-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817012031850K-6 TURN-ZONEKAP MEDICALIKZ2026-01-16
00817012031829K-6oem AIRE-TURN ASSIST KAP MEDICALIKZ2025-10-10
00817012031843K-Zoem EZ-TURNKAP MEDICALIKZ2025-10-10
00817012031775K-6oem AIRE-TURN ASSIST KAP MEDICALIKZ2025-09-26
00817012031782K-6oem AIRE-TURN ASSIST KAP MEDICALIKZ2025-09-26
00817012031799K-6oem AIRE-TURN ASSIST KAP MEDICALIKZ2025-09-26
00817012031737K-6 TURN-ZONEKAP MEDICALIKZ2025-09-04
00817012022179K-Z ZM ZMattKAP MEDICALIKZ2025-06-27
00817012031676K-Zoem EZ-TURNKAP MEDICALIKZ2025-04-04
00817012031621K-6 AIRE-TURN ASSISTKAP MEDICALIKZ2024-11-22
00817012031638K-Z EZ-TURNKAP MEDICALIKZ2024-11-22
00817012031607K-Z Z-TURNKAP MEDICALIKZ2024-09-20
00817012031614K-Z Z-TURNKAP MEDICALIKZ2024-09-20
B414PAR3A3FXX0The Freedom BedProBed Medical Technologies IncIKZ2024-09-05
00817012031577K-Z ZM ZMattKAP MEDICALIKZ2024-08-23
00817012031584K-Zoem EZ-TURNKAP MEDICALIKZ2024-08-23
00817012031591K-Z ZM ZMattKAP MEDICALIKZ2024-08-23
00817012031492K-Z ZM ZMattKAP MEDICALIKZ2024-07-19
00817012031546K-Z Z-TURNKAP MEDICALIKZ2024-07-19
00860006962203Pronova-O2Turn Medical, LLCIKZ2024-06-03
00860011685609SideLyerTHE SIDE LYER COMPANY, LLCIKZ2024-04-29
00817012031355K-6 TURN-ZONEKAP MEDICALIKZ2024-01-19
00817012031362K-6 TURN-ZONEKAP MEDICALIKZ2024-01-19
00860004936817EasyShiftSeneca Devices, Inc.IKZ2024-01-12
00860004936848EasyShiftSeneca Devices, Inc.IKZ2024-01-12
00817012031386K-6 TURN-ZONEKAP MEDICALIKZ2023-11-30
00817012031379K-Z Z-TURNKAP MEDICALIKZ2023-08-11
00817012031348K-6 TURN-ZONEKAP MEDICALIKZ2023-07-14
00817012031164K-Z iTURNKAP MEDICALIKZ2023-06-02
00817012031171K-Z iTURNKAP MEDICALIKZ2023-06-02