FDA.reportPublic FDA data

Aluna

Primary DI
00860000654005
Brand
Aluna
Company
KNOX MEDICAL DIAGNOSTICS INC.
Model
000050-FGI
Device description
Aluna Spirometer
Published
2020-09-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true

Product Codes#

Code, Name table
CodeName
BZHMeter, Peak Flow, Spirometry

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZHMeter, Peak Flow, SpirometryAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193311000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193311000AlunaKnox Medical Diagnostics, Inc.2020-03-25BZH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860000654005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860000654005008600006540058600006540050860000654005

GMDN Terms#

Term, Definition table
TermDefinition
Peak flow meter, electronicA battery-powered, hand-held instrument designed to measure the maximum rate of expiratory gas flow [peak expiratory flow (PEF) or peak expiratory flow rate (PEFR)] and forced expiratory volume (FEV) from the lungs. It typically includes a mouthpiece for patient exhalation and a digital display [e.g., liquid-crystal display (LCD)]; it may include a port for communicating with a personal computer (PC). The device is typically intended to monitor the respiratory status of a patient suffering from chronic respiratory disease (e.g., asthama, emphysema) in a clinical setting or the home.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature-20 Degrees Celsius60 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius45 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079168163
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816042015045FORAFORA CARE INC.BZH2026-05-18
00816042015052FORAFORA CARE INC.BZH2026-05-18
00860013746407NxGen Peak Flow MeterSAFEY MEDICAL DEVICES PRIVATE LIMITEDBZH2025-01-27
00198715485813NxGen Peak Flow MeterSAFEY MEDICAL DEVICES PRIVATE LIMITEDBZH2025-01-27
00311917047201WalgreensWALGREEN CO.BZH2024-03-12
10193489149722HUDSON RCIMEDLINE INDUSTRIES, INC.BZH2024-02-07
20193489149729HUDSON RCIMEDLINE INDUSTRIES, INC.BZH2024-02-07
06975038051017sonmolChongqing Moffy Innovation Technology Co., Ltd.BZH2024-01-17
00311917034980WalgreensWALGREEN CO.BZH2023-08-21
10311917034987WalgreensWALGREEN CO.BZH2023-08-21
G004TCPFMA10TenoviTenovi Co.BZH2022-11-01
00642632732050microlifeMICROLIFE USA, INC.BZH2022-06-02
10642632732057microlifeMICROLIFE USA, INC.BZH2022-06-02
05099169439115PFMVITALOGRAPH (IRELAND) LIMITEDBZH2022-04-29
55099169439110PFMVITALOGRAPH (IRELAND) LIMITEDBZH2022-04-29
08908014292010Safey Peak Flow MeterSAFEY MEDICAL DEVICES PRIVATE LIMITEDBZH2022-02-04
00810025922276caring millCaring MillBZH2021-06-09
10810025922273caring millCaring MillBZH2021-06-09
04897100310162Andnesfit HealthANDESFIT LIMITEDBZH2021-05-03
00840117319035Resp-O2 Peak Flow Meter Low Range 50-300 L/minDynarex CorporationBZH2021-04-22
00840117319042Resp-O2 Peak Flow Meter Full Range 50-800 L/minDynarex CorporationBZH2021-04-22
00840117318786Resp-O2 Peak Flow MeterDYNAREX CORPORATIONBZH2021-04-22
00840117318793Resp-O2 Peak Flow MeterDYNAREX CORPORATIONBZH2021-04-22
06922649905048M&BBeijing M&B Electronic Instruments Co., Ltd.BZH2021-04-20
06922649905055M&BBeijing M&B Electronic Instruments Co., Ltd.BZH2021-04-20
10884389144558MedlineMEDLINE INDUSTRIES, INC.BZH2021-04-01
40884389144559MedlineMEDLINE INDUSTRIES, INC.BZH2021-04-01
B005001730AincA®ANESTHESIA ASSOCIATES, INC.BZH2021-03-31
B005001740AincA®ANESTHESIA ASSOCIATES, INC.BZH2021-03-31
B0050017420AincA®ANESTHESIA ASSOCIATES, INC.BZH2021-03-31