FDA.reportPublic FDA data

Fenom Flo™

Primary DI
00810016252283
Brand
Fenom Flo™
Company
MEDICAL GRAPHICS CORPORATION
Model
701098-001
Catalog number
800861-001
Device description
Fenom Flo™ FeNO Monitoring System
Published
2026-06-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
MXASystem, Test, Breath Nitric Oxide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MXASystem, Test, Breath Nitric OxideClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251674000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251674000Fenom Flo™ FeNO Monitoring SystemMgc Diagnostics Corporation2025-11-26MXA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810016252306PackageGS11In Commercial Distribution
00810016252283PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810016252306008100162523068100162523060810016252306
00810016252283008100162522838100162522830810016252283

GMDN Terms#

Term, Definition table
TermDefinition
Nitrogen monoxide analyserAn electrically-powered device intended to measure nitric oxide (NO), also known as nitrogen monoxide, in exhaled air to facilitate diagnosis and management of asthma. Measurements are used to calculate fractional exhaled nitric oxide (FeNO) at different levels of the respiratory tract (e.g., bronchial, alveolar, nasal). It typically consists of a software-controlled, electronic unit and an attached tube for collection of expired air. It may also provide spirometry measurements.

Regulatory Flags#

DUNS number
094045622
Device count
1
DM exempt
false
Premarket exempt
false
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810016252252Assy Meridian Series790708-0012026-06-10
00810016252269SW ASCENT 2.4.0 DOWNLOAD148025-5022026-06-10
00810016252290Fenom Flo™148029-5022026-06-10
00810016252313SW Ascent 2.5 Download148033-5022026-06-10
00810016252320Fenom Flo™155235-0012026-06-10
00810016250555Medical Graphics147999-0042023-07-18
00810016250579Medical Graphics147999-5022023-07-18
00810016250616Medical Graphics536018-001 2023-06-14
00810016250340MGC Diagnostics762042-003800704-0032019-02-22
00810016250357MGC Diagnostics762042-904800704-9042019-02-22
00810016250364MGC Diagnostics762042-905800704-9052019-02-22
B3687620420030MGC Diagnostics762042-003800704-0032017-01-12
B3687620429040MGC Diagnostics762042-904800704-9042018-06-18
B3687620429050MGC Diagnostics762042-905800704-9052018-06-18
B368700023905MGC Diagnostics700023-905700023-9052016-09-09
B3687000239060MGC Diagnostics700023-9062018-06-18
B368800810001MGC Diagnostics800810-001800810-0012016-09-09
B368800810011MGC Diagnostics800810-011800810-0112016-09-09
B3688008100210MGC Diagnostics800810-0212018-06-18
B3688008100310MGC Diganostics800810-0312018-06-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810016252290Fenom Flo™MEDICAL GRAPHICS CORPORATIONMXA2026-06-10
05060246860191NObreath®BEDFONT SCIENTIFIC LIMITEDMXA2026-03-09
04059233002813Spare part: Vivatmo pro handheld USBosch Healthcare Solutions GmbHMXA2024-07-08
04059233002820Spare part: Vivatmo pro base station USBosch Healthcare Solutions GmbHMXA2024-07-08
04059233000048Vivatmo pro OxycapBosch Healthcare Solutions GmbHMXA2024-07-08
04059233000307Vivatmo pro Level 0Bosch Healthcare Solutions GmbHMXA2024-07-08
04059233001274Vivatmo proBosch Healthcare Solutions GmbHMXA2024-07-08
04059233000130Spare part: Vivatmo pro handheld USBosch Healthcare Solutions GmbHMXA2024-07-08
04059233000123Spare part: Vivatmo pro base station USBosch Healthcare Solutions GmbHMXA2024-07-08
00860008017901CAIRE DiagnosticsCaire Diagnostics Inc.MXA2022-01-31
00860008017918CAIRE DiagnosticsCaire Diagnostics Inc.MXA2022-01-31
00860008017925CAIRE DiagnosticsCaire Diagnostics Inc.MXA2022-01-31
00860008017932CAIRE DiagnosticsCaire Diagnostics Inc.MXA2022-01-31
00860008017949CAIRE DiagnosticsCaire Diagnostics Inc.MXA2022-01-31
00860008017956CAIRE DiagnosticsCaire Diagnostics Inc.MXA2022-01-31
05060246860177NOBreathBEDFONT SCIENTIFIC LIMITEDMXA2022-01-06
05060246860320FeNOBreathBEDFONT SCIENTIFIC LIMITEDMXA2022-01-06
07350047030663NIOXCircassia ABMXA2021-10-28
07350047030670NIOXCircassia ABMXA2021-10-28
07350047030687NIOXCircassia ABMXA2021-10-28
07350047030694NIOXCircassia ABMXA2021-10-28
07350047030700NIOXCircassia ABMXA2021-10-28
07350047030717NIOXCircassia ABMXA2021-10-28
07350047030458NIOXCircassia ABMXA2016-09-21
07350047030465NIOXCircassia ABMXA2016-09-21
07350047030052NIOXCircassia ABMXA2016-09-21
07350047030069NIOXCircassia ABMXA2016-09-21
07350047030076NIOXCircassia ABMXA2016-09-21
07350047030106NIOXCircassia ABMXA2016-09-21
07350047030113NIOXCircassia ABMXA2016-09-21