FDA.report

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
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
IQASystem, Environmental Control, Powered

Product Code Classifications

CodeDeviceSpecialtyClass
IQASystem, Environmental Control, PoweredPhysical Medicine2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B1751CB11PrimaryHIBCC0

GMDN Terms

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

Contacts

PhoneEmail
8552820004info@loonmedical.com

Regulatory Flags

DUNS number
079266770
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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 Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00840828196178JUMPER,6",S102 TO 7 PIN DINCURBELL MEDICAL PRODUCTS, INC.IQA2026-03-20
B484DARPSM50094A0Elite Digital Pillow Speaker for Critical Alert, 8-pin DIN, Nurse, PTW, BeepCrest Healthcare SupplyIQA2026-03-13
00840828196109GEN4 PLUS, DIRECT ACCESSCURBELL MEDICAL PRODUCTS, INC.IQA2026-03-11
00840828196116GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-03-11
00840828196161GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-03-11
00840828196079GEN4 DIRECT ACCESSCURBELL MEDICAL PRODUCTS, INC.IQA2026-03-04
00840828196086GEN4 DIRECT ACCESSCURBELL MEDICAL PRODUCTS, INC.IQA2026-03-04
00840828196000GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-03-03
00840828196017GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-03-03
00840828196031GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-03-03
00840828196055GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-03-03
00840828196062GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-03-03
00840828195928GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-02-05
00840828195935GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-02-05
00840828195904GEN4 PLUS, DIRECT ACCESSCURBELL MEDICAL PRODUCTS, INC.IQA2026-02-03
17350088671433AscomAscom (Sweden) ABIQA2026-02-02
00840948103414Securitas HealthcareSecuritas Healthcare LLCIQA2026-01-13
00840948103421Securitas HealthcareSecuritas Healthcare LLCIQA2026-01-13
00840948103438Securitas HealthcareSecuritas Healthcare LLCIQA2026-01-13
00840948103445Securitas HealthcareSecuritas Healthcare LLCIQA2026-01-13
00840948103452Securitas HealthcareSecuritas Healthcare LLCIQA2026-01-13
00840948103469Securitas HealthcareSecuritas Healthcare LLCIQA2026-01-13
00840828195867GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-01-07
00840828195829GEN4 DIRECT ACCESSCURBELL MEDICAL PRODUCTS, INC.IQA2025-12-30
00840828195836GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2025-12-30
00840828195843GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2025-12-30
00840828195805GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2025-12-16
00840828195508GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2025-12-09
00840828195515GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2025-12-09
00840828195522GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2025-12-09