Cognito Health

Primary DI
14719889980039
Brand
Cognito Health
Company
Cognito Health Inc.
Model
BA6E-32
Published
2022-11-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
PJOFall Prevention Alarm/Sensor Combination Attached Or Unattached

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PJOFall Prevention Alarm/Sensor Combination Attached Or UnattachedGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14719889980039PackageGS16In Commercial Distribution
24719889980036PackageGS13In Commercial Distribution
04719889980032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1471988998003914719889980039
2471988998003624719889980036
04719889980032047198899800324719889980032

GMDN Terms#

Term, Definition table
TermDefinition
Nurse call system alarmAn electronic device intended to provide an audible sound and/or a visual display, typically coloured flashing lights or scrolling text, to notify a medical professional that (urgent) assistance is needed by a patient. It may be in the form of dome lights, basic visual display screens, and/or beeping devices which are triggered by manual or automatic alert activators (e.g., bedside push-button, ambulatory fall sensor, bed occupancy sensor) [not included]; it may function independently or as a component of a nurse call system via the healthcare facility hardwired or wireless network.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
657327248
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
true
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 From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719889980018Cognito HealthP7FD-212022-11-25
04719889980032Cognito HealthBA6E-322022-11-25
04719889980049Cognito HealthBA6E-312022-11-25
14719889980015Cognito HealthP7FD-212022-11-25
04719889980025Cognito HealthBA6E-312022-11-25
14719889980046Cognito HealthBA6E-312022-11-25
04719889980056Cognito HealthBA6E-322022-11-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05745001037000Teton Fall DetectionTeton.AI ApSPJO2025-01-01
04719889980032Cognito HealthCognito Health Inc.PJO2022-11-25
04719889980049Cognito HealthCognito Health Inc.PJO2022-11-25
04719889980025Cognito HealthCognito Health Inc.PJO2022-11-25
14719889980046Cognito HealthCognito Health Inc.PJO2022-11-25
04719889980056Cognito HealthCognito Health Inc.PJO2022-11-25
00816317024031Posey RENU MEDICAL, INCPJO2022-08-18
00816317024048PoseyRENU MEDICAL, INCPJO2022-08-18
10816317024038Posey RENU MEDICAL, INCPJO2022-08-18
10816317024045PoseyRENU MEDICAL, INCPJO2022-08-18
B4841140530FALL FIGHTER,STRING MONITORCrest Healthcare SupplyPJO2018-07-20