FDA.reportPublic FDA data

CareSentinell

Primary DI
B1751CB11
Brand
CareSentinell
Company
LOON MEDICAL, INC.
Model
CB11
Catalog number
CB11
Device description
CareSentinel call button
Published
2016-05-06
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IQASystem, Environmental Control, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQASystem, Environmental Control, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B1751CB11PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bed remote controlA hand-operated electronic device that has a functional connection to an electrically-powered medical bed to control its functions, typically the articulations and/or the raising/lowering of the bed. It may be connected to the bed via an electrical cable or operate cordless (wireless). It is typically operated by the occupant but may be utilized by the nursing/attending staff. Some types may integrate other functions for patient use (e.g., communication with the staff, radio/television operation).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8552820004info@loonmedical.com

Regulatory Flags#

DUNS number
079266770
Device count
1
Premarket exempt
true
Serial number
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840828196666GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-06-09
00840828196673GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-06-09
00840828196475GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27
00840828196482GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27
00840828196499GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27
00840828196505GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27
00840828196512GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27
00840828196529GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27
00840828196536GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27
00840828196543GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27
00840828196550GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27
00840828196567GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27
00840828196574GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27
00840828196581GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27
00840828196598GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27
00840828196604GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27
00840828196611GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27
00840828196628GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27
00840828196635GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27
00840828196642GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27
00840828196659GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27
00840828196444GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-19
00840828196451GEN4 PLUS, DIRECT ACCESSCURBELL MEDICAL PRODUCTS, INC.IQA2026-05-19
00840828196406GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-07
00840828196413GEN4 PLUS, DIRECT ACCESSCURBELL MEDICAL PRODUCTS, INC.IQA2026-05-07
00840828196437GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-07
00840828196369GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-04-23
00840828196376GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-04-23
00840828196383GEN4 PLUS, DIRECT ACCESSCURBELL MEDICAL PRODUCTS, INC.IQA2026-04-23
00840828196390GEN4 PLUS, DIRECT ACCESSCURBELL MEDICAL PRODUCTS, INC.IQA2026-04-23