FDA.reportPublic FDA data

Hill-Rom

Primary DI
00841965101483
Brand
Hill-Rom
Company
Tridien Medical
Model
Compella
Catalog number
23SM-RLN-FRM-BH
Device description
Controller, CMP, LV,FRE,MKS,BH
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

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
00841965101483PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841965101483008419651014838419651014830841965101483

GMDN Terms#

Term, Definition table
TermDefinition
Rotation bed, electricA mains electricity (AC-powered) bed that provides automated rotation of the patient in a circular framework using electric power. It is used for patients with severe fractures and/or spinal cord injuries to provide an essential periodic change (i.e., rotation) of the patient's body position.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1 800 474 4225info@tridien.com

Regulatory Flags#

DUNS number
625060962
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841965100486IsoAir294045A-SR5-35842017-01-13
00841965100493IsoAir294045A-SR5-32802017-01-13
00841965100509IsoAir294045A-SR5-35802017-01-13
00841965100516IsoAir294045A-SR8-32802017-01-13
00841965100523IsoAir294045A-SR8-35802017-01-13
00841965100554SenTechAir Chair77-SM22BAC-B2017-01-27
00841965100592Stryker Air286160SM-20002017-01-13
00841965100608IsoAir294012SM-SRLV-BH2017-01-13
00841965100615IsoAir294012SM-USLV-KIT2017-01-13
00841965100622IsoAir2940SYS-SR-0022017-01-13
00841965100653SenTechSentry 125012-SM50-R2016-09-19
00841965100660IsoAir294012SM-EUHV-KIT2017-01-13
00841965100677IsoAir294012SM-SALV-KIT2017-01-13
00841965100684Stryker Air286160SM-30002017-01-13
00841965100691IsoAir294012SM-SRHV-E2017-01-13
00841965100707Stryker Air286260SM-40002017-01-13
00841965100714IsoAir294012SM-SRHV-G2017-01-13
00841965100721Stryker Air286260SM-40012017-01-13
00841965100745IsoAir294012SM-SRHV-I2017-01-13
00841965100752IsoAir294012SM-SRHV-J2017-01-13

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