FDA.reportPublic FDA data

AincA®

Primary DI
B005001730
Brand
AincA®
Company
ANESTHESIA ASSOCIATES, INC.
Model
00-173
Catalog number
00-173
Device description
Peak Flow Meter, Std Mini-Wright, 60-800 lpm, SinglePatient, w/Mouthpiece (See 00-177/00-281)
Published
2021-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
K851265000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K851265000PEAK FLOWMETERS FOR SPIROMETRYSolcoor, Inc.1985-10-29BZH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B005001730PrimaryHIBCC0

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
+1(760)744-6561Solutions@AincA.com

Regulatory Flags#

DUNS number
002065670
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B005002370AincA®00-23700-2372021-03-31
B005002380AincA®00-23800-2382021-03-31
B005004070AincA®00-40700-4072021-03-31
B00500407S0AincA®00-407-S00-407-S2021-03-31
B005004080AincA®00-40800-4082021-03-31
B00500408S0AincA®00-408-S00-408-S2021-03-31
B00500675A0AincA®00-675-A00-675-A2021-03-31
B00500675A10AincA®00-675-A-100-675-A-12021-03-31
B00500675B0AincA®00-675-B00-675-B2021-03-31
B00500675B10AincA®00-675-B-100-675-B-12021-03-31
B00500675BDEMO0AincA®00-675-B-DEMO00-675-B-DEMO2021-03-31
B00500675C0AincA®00-675-C00-675-C2021-03-31
B00500675C10AincA®00-675-C-100-675-C-12021-03-31
B00500675CASE0AincA®00-675-CASE00-675-CASE2021-03-31
B00500675LCD0AincA®00-675-LCD00-675-LCD2021-03-31
B00500675V0AincA®00-675-V00-675-V2021-03-31
B00500675V10AincA®00-675-V-100-675-V-12021-03-31
B005LF143B0AincA®LF-143-BLF-143-B2021-03-31
B005LF143C0AincA®LF-143-CLF-143-C2021-03-31
B005003800AincA®00-38000-3802021-03-31

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
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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
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
B005001740AincA®ANESTHESIA ASSOCIATES, INC.BZH2021-03-31
B0050017420AincA®ANESTHESIA ASSOCIATES, INC.BZH2021-03-31
00193489019066MedlineMEDLINE INDUSTRIES, INC.BZH2021-03-12