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
00840828197021GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-10-15
00840828197038GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-10-15
00840828197052GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-10-15
00840828197090GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-10-15
00840828197106GEN4 DIRECT ACCESSCURBELL MEDICAL PRODUCTS, INC.IQA2026-10-15
00840828197113GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-10-15
00840828197137GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-10-15
00840828197229GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-10-15
00840828197236GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-10-15
00840828197243GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-10-15
00812664024564TekTone Sound & Signal Mfg., Inc.TEKTONE SOUND AND SIGNAL, MFG., INC.IQA2026-09-30
B4849916DXYY0DuraCall Call Cord for Tektone Tek-CARE300III, Dual, 8pin DINCrest Healthcare SupplyIQA2026-09-29
00812664020047TekTone Sound & Signal Mfg., Inc.TEKTONE SOUND AND SIGNAL, MFG., INC.IQA2026-08-26
00812664024557TekTone Sound & Signal Mfg., Inc.TEKTONE SOUND AND SIGNAL, MFG., INC.IQA2026-08-21
00812664024779TekTone Sound & Signal Mfg., Inc.TEKTONE SOUND AND SIGNAL, MFG., INC.IQA2026-08-21
00812664024939TekTone Sound & Signal Mfg., Inc.TEKTONE SOUND AND SIGNAL, MFG., INC.IQA2026-08-21
00812664025127TekTone Sound & Signal Mfg., Inc.TEKTONE SOUND AND SIGNAL, MFG., INC.IQA2026-08-19
00812664024700TekTone Sound & Signal Mfg., Inc.TEKTONE SOUND AND SIGNAL, MFG., INC.IQA2026-08-18
00812664024717TekTone Sound & Signal Mfg., Inc.TEKTONE SOUND AND SIGNAL, MFG., INC.IQA2026-08-18
00812664024724TekTone Sound & Signal Mfg., Inc.TEKTONE SOUND AND SIGNAL, MFG., INC.IQA2026-08-18
00812664024731TekTone Sound & Signal Mfg., Inc.TEKTONE SOUND AND SIGNAL, MFG., INC.IQA2026-08-18
00812664024892TekTone Sound & Signal Mfg., Inc.TEKTONE SOUND AND SIGNAL, MFG., INC.IQA2026-08-18
00812664024908TekTone Sound & Signal Mfg., Inc.TEKTONE SOUND AND SIGNAL, MFG., INC.IQA2026-08-18
00812664024915TekTone Sound & Signal Mfg., Inc.TEKTONE SOUND AND SIGNAL, MFG., INC.IQA2026-08-18
00812664025134TekTone Sound & Signal Mfg., Inc.TEKTONE SOUND AND SIGNAL, MFG., INC.IQA2026-08-18
00812664025141TekTone Sound & Signal Mfg., Inc.TEKTONE SOUND AND SIGNAL, MFG., INC.IQA2026-08-18
00840828197007GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-08-18
00840828196864GEN4 DIRECT ACCESSCURBELL MEDICAL PRODUCTS, INC.IQA2026-07-23
00840828196871GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-07-23
00840828196758GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-07-08