FDA.reportPublic FDA data

AincA®

Primary DI
B00500281P0500
Brand
AincA®
Company
ANESTHESIA ASSOCIATES, INC.
Model
00-281-P-050
Catalog number
00-281-P-050
Device description
Mouthpiece, Disposable, Pediatric, fits (00-174) Low Range Mini-Wright, Pack of 50
Published
2021-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZGSPIROMETER, DIAGNOSTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZGSpirometer, DiagnosticAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B00500281P0506PrimaryHIBCC0
B00500281P0500Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Incentive spirometerA hand-held, mechanical, breathing-muscle exerciser used in respiratory therapy to encourage and motivate deep-breathing manoeuvres, typically for the postsurgical treatment and prevention of atelectasis (lung collapse) and to help facilitate airway opening and clearing. It typically includes an indicator in a housing that rises in relation to patient inspiratory effort, performed via an attached tube and mouthpiece, to determine the maximum volume of gas which can be inspired [i.e., the inspiratory vital capacity (IVC)]. This is a single-patient device designed for use in a medical facility or in the home. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(760)744-6561Solutions@AincA.com

Regulatory Flags#

DUNS number
002065670
Device count
50
DM exempt
false
Premarket exempt
true
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
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B00500251DMRI0AincA00-251-D-MRI00-251-D-MRI2024-06-18
B005D00313P060AincA®D-00-313-P-06D-00-313-P-062024-06-18
B005D00313P080AincA®D-00-313-P-08D-00-313-P-082024-06-18
B005D00323060AincA®D-00-323-06D-00-323-062024-06-18
B005D00323080AincA®D-00-323-08D-00-323-082024-06-18
B005LF619100AincA®LF-619-10LF-619-102023-08-17
B005LF619200AincA®LF-619-20LF-619-202023-08-17
B005LF619300AincA®LF-619-30LF-619-302023-08-17
B005LF619400AincA®LF-619-40LF-619-402023-08-17
B005LF619500AincA®LF-619-50LF-619-502023-08-17
B005LF622100AincA®LF-622-10LF-622-102023-08-17
B005LF622200AincA®LF-622-20LF-622-202023-08-17
B005LF622300AincA®LF-622-30LF-622-302023-08-17
B005LF622400AincA®LF-622-40LF-622-402023-08-17
B005LF622500AincA®LF-622-50LF-622-502023-08-17
B005LF715100AincA®LF-715-10LF-715-102023-08-17
B005LF715200AincA®LF-715-20LF-715-202023-08-17
B005LF715300AincA®LF-715-30LF-715-302023-08-17
B005LF715400AincA®LF-715-40LF-715-402023-08-17
B005LF715500AincA®LF-715-50LF-715-502023-08-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809276943958Cardio Q50, Cardio Q70Bionet CO,LTDBZG2026-05-26
08809276943965Cardio Q50, Cardio Q70Bionet CO,LTDBZG2026-05-26
08809276944269Cardio Q50, Cardio Q70Bionet CO,LTDBZG2026-05-26
08809276944276Cardio Q50, Cardio Q70Bionet CO,LTDBZG2026-05-26
03830059852216MESI mTABLET SPIROMESI d.o.o.BZG2026-03-24
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050991698301272120 In2itive - BrazilVITALOGRAPH (IRELAND) LIMITEDBZG2025-04-30
08052990321704MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2025-02-27
00860013746414NxGen Pocket SpirometerSAFEY MEDICAL DEVICES PRIVATE LIMITEDBZG2025-01-27
00198715872873NxGen Pocket SpirometerSAFEY MEDICAL DEVICES PRIVATE LIMITEDBZG2025-01-27
08052990320240MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2024-11-25
08052990320257MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2024-11-25
08052990320264MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2024-11-25
08052990320271MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2024-11-25
08052990320424MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2024-11-25
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