FDA.reportPublic FDA data

SpiroFlow

Primary DI
00855784004054
Brand
SpiroFlow
Company
Spirometrics
Model
E5020
Catalog number
E5020-2
Device description
Child Peak Flow Meter
Published
2016-10-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

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
K915059000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K915059000PEAK FLOW MONITORSpirometrics, Inc.1992-07-27BZH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855784004054PackageGS12In Commercial Distribution
00855784004061PackageGS18In Commercial Distribution
00855784004238PackageGS112In Commercial Distribution
00855784004047PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855784004054008557840040548557840040540855784004054
00855784004061008557840040618557840040610855784004061
00855784004238008557840042388557840042380855784004238
00855784004047008557840040478557840040470855784004047

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

Contacts#

Phone, Email table
PhoneEmail
207-657-6700info@spirometrics.com

Regulatory Flags#

DUNS number
830864406
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00855784004009VeinsiteVTS10002018-12-04
00855784004269Spiro-FilterD10102016-10-11
00855784004276SpirometricsD10302017-04-03
00855784004283SpirometricsD10202017-04-03
00855784004016SpiroFlowE5010E5010-22016-10-11
00855784004047SpiroFlowE5020E5020-22016-10-11
00855784004290SpirometricsD10602017-04-03
00855784004207SpirometricsN4010N4010-22017-04-03
00855784004214SpirometricsN4010N4010-2-VAC2017-04-03
00855784004245SpiroFlowE5010E5010-2-NOV2016-10-11
00855784004252SpiroFlowE5020E5020-2-NOV2016-10-11
00855784004085Spiro-FilterD10102016-10-11
00855784004160SpirometricsD10302017-04-03
00855784004146SpirometricsD10202017-04-03
00855784004030SpiroFlowE5010E5010-22016-10-11
00855784004191SpirometricsD10602017-04-03

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00816042015052FORAFORA CARE INC.BZH2026-05-18
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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
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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