FDA.reportPublic FDA data

Canary Flight Plan

Primary DI
00850015699160
Brand
Canary Flight Plan
Company
Canary Medical USA LLC
Model
v.1.0.0
Published
2026-08-07
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
OUGMedical Device Data System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OUGMedical Device Data SystemGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850015699160PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850015699160008500156991608500156991600850015699160

GMDN Terms#

Term, Definition table
TermDefinition
Biomechanical function analysis/rehabilitation softwareA software package intended to be used by patients and clinicians to receive and display a patient’s physical exercise/movement/action data [e.g., kinesiology/gait data (walking speed or distance)] to facilitate analysis as part of physical assessment/rehabilitation. It is intended to be used while using an interactive rehabilitation system, biomechanical function analysis system and/or kinesiology recorder (ambulatory or implantable). It might be intended to function in conjunction with a motion-sensing system/device or limb-support robotic system, and may be capable of storing and/or enable viewing of patient performance data.

Regulatory Flags#

DUNS number
117153396
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
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 From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850015699177Canary Recovery Curvev.1.12026-08-07
00850015699115CanarE Strap43-5570-007-162023-05-17
00850015699061 canturio™te Impaction Sleeve43-5399-001-142021-09-22
00860003118399Canturio® Smart Extension 14mm (D) x 30mm (H)43-5570-030-142024-09-12
00850015699153Home Base Station (Bluetooth)43-5570-001-152024-09-06
00850015699122Canary Clinic Cart43-5570-008-142023-05-17
00850015699139CanarE Charging Cradle43-5570-007-152023-05-17
00860003118344CanarE – Clinic Wearable Device43-5570-007-142023-05-17
00860003118368Canary Clinic Base Station43-5570-005-142023-05-17
00860003118382Clinic Laptop43-5570-003-152023-05-17
00850015699009 canturio™te Cemented Tibia Drill Bit43-5399-058-142021-09-22
00850015699023 canturio™te Tibia Resection Cutting Guide, Left, 5 Deg.43-5399-051-052021-09-22
00850015699054 canturio™te Tibia Resection Cutting Guide, Right, 5 Deg.43-5399-052-052021-09-22
00850015699030 canturio™te Modular Bracket Stem Provisional1100436132021-09-22
00850015699047 canturio™te Modular Bracket Drill Bit1100436142021-09-22
00850015699078 canturio™te Modular Bracket Tibial Cutting Guide, Left; 5 Deg.43-5907-080-272021-09-22
00850015699085 canturio™te Modular Bracket Tibial Cutting Guide, Right; 5 Deg.43-5907-080-292021-09-22
00850015699108canturio™ te Modular Bracket, Impaction Sleeve1100445052021-09-22
00860003118351 canturio™te Provisional43-5571-058-142021-09-22
00860003118313Canary OR Base Station / OR PC App / OR Registration43-5570-002-142021-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850015699177Canary Recovery CurveCanary Medical USA LLCOUG2026-08-07
04048675544227Connectivity Converter CC300Drägerwerk AG & Co. KGaAOUG2026-07-17
04260658860258myoncareONCARE GmbHOUG2026-07-17
00840241600443Kestra Provided Device Patient ApplicationKestra Medical Technologies, Inc.OUG2026-07-16
00884400004871GoClinicMonitored Therapeutics, Inc.OUG2026-07-16
00884400085481GoMobileMonitored Therapeutics, Inc.OUG2026-07-16
04035479194192PatientApp 2.10.0BIOTRONIK SE & Co. KGOUG2026-07-16
00884838132337Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-07-13
00884838132344Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-07-13
04048675558552Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
04048675558569Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
04048675558576Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
04048675663997Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
00199150006038N/AMEDTRONIC, INC.OUG2026-05-23
04931921049464NANIHON KOHDEN CORPORATIONOUG2026-05-20
04931921111697NANIHON KOHDEN CORPORATIONOUG2026-05-20
00199150021277NAMEDTRONIC, INC.OUG2026-05-02
00199150042784NAMEDTRONIC, INC.OUG2026-04-30
00199874112060CliniSphereMonitored Therapeutics, Inc.OUG2026-04-28
00850022853036ProSomnus RPMO2 OSA DevicePROSOMNUS SLEEP TECHNOLOGIESOUG2026-04-24
00884838129238Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-04-17
00884838129245Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-04-17
00199150002191N/AMEDTRONIC, INC.OUG2026-04-02
05404028001158Mimics FlowMaterialise NVOUG2026-03-23
05404028001172SurgiCase OnlineMaterialise NVOUG2026-03-23
05404028001189ProPlan CMF Materialise NVOUG2026-03-23
00763000994914NAMEDTRONIC, INC.OUG2026-03-22
00382904450106BD Veritor™ InfoWiFi ModuleBECTON, DICKINSON AND COMPANYOUG2026-03-13
00884838129214Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-03-09
00884838129221Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-03-09