FDA.reportPublic FDA data

OVAL MOUTHPIECE

Primary DI
00383730004648
Brand
OVAL MOUTHPIECE
Company
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD
Model
1136960
Catalog number
1136960
Device description
OVAL MOUTHPIECE
Published
2020-06-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
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
K962924000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K962924000PERSONAL BEST II WITH ZONE MANAGEMENT SYSTEMHealthscan Products, Inc.1996-10-25BZH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00383730004648PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00383730004648003837300046483837300046480383730004648

GMDN Terms#

Term, Definition table
TermDefinition
Peak flow meter, manualA manual, hand-held instrument designed to measure only the maximum rate of expiratory gas flow [peak expiratory flow (PEF) or peak expiratory flow rate (PEFR)] from the lungs. It typically includes a tube for patient exhalation, an easy-to-grip handle, and a calibrated scale that shows the value of the peak flow. The device helps to discriminate the pulmonary status in routine tests performed in or outside of a clinical setting; it is also intended for periodic self-evaluation of the respiratory status of a patient, and to help in the treatment evaluation of patients suffering from chronic respiratory disorders (e.g., asthma, emphysema).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
220018415
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00383730000657ProChamber Assembly00HS-0062016-08-24
00383730000664PROCHAMBER Assembly0010401912016-08-24
00383730000671PROCHAMBER Assembly0010691772016-08-24
00383730000688ProChamber Assembly0011174882016-08-24
00383730000695ProChamber Assembly0011174892016-08-24
00383730000701ProChamber Assembly0011174902016-08-24
00383730000718ProChamber Assembly00HS2003-0502016-08-24
00383730004013INNOSPIRE ESSENCE112740911274092019-06-27
00383730003993Innospire Essence112954211295422019-06-17
00383730004006INNOSPIRE ESSENCE112953911295392019-06-17
00383730004037Innospire Essence112818211281822019-06-17
00383730004419Innospire Elegance0011368252019-06-10
00383730001050SideStream0010468382016-08-24
00383730001067SideStream0012012016-08-24
00383730001074Sidestream0010594872016-08-24
00383730001081SideStream0010722862016-09-21
00383730001098SideStream001200A2016-08-24
00383730001104Sidestream001223A2016-08-24
00383730001111Sidestream001224A2016-08-24
00383730001210SideStream001225A2016-08-24

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