FDA.reportPublic FDA data

AincA®

Primary DI
B005001450
Brand
AincA®
Company
ANESTHESIA ASSOCIATES, INC.
Model
00-145
Catalog number
00-145
Device description
Respirometer Guard - Fits Mark 8, 14, 25, HS compact & Phys, w/Closure O-Rings, Black Neoprene
Published
2021-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZKSpirometer, monitoring (w/wo alarm)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZKSpirometer, Monitoring (W/Wo Alarm)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B005001450PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Breathing circuit gas-flow sensor, reusableA device that includes a transducer intended to detect the movement of gases in a breathing circuit, and convert this into an electrical signal for relay to a ventilator (e.g., adult/paediatric/neonatal ventilators, anaesthesia system ventilators). It is connected to the breathing circuit and an appropriate data transfer cable and intended to enable the ventilator to display/monitor the gas flow to and from the patient, whereby controlled adjustments may be made. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
002065670
Device count
1
DM exempt
true
Premarket exempt
true
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
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyBZK2026-04-15
00851540007161ExSpiron Pediatric PadSetsSenzime AB (Publ.)BZK2024-01-25
05065016557004KoKoKOKO PFT LTDBZK2023-08-01
05065016557011KoKoKOKO PFT LTDBZK2023-08-01
05065016557028KoKoKOKO PFT LTDBZK2023-08-01
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyBZK2023-04-19
00195278522320CARESCAPE Canvas 1000GE Healthcare Finland OyBZK2023-04-19
00195278523365CARESCAPE Canvas D19GE Healthcare Finland OyBZK2023-04-19
00195278524089NAGE Healthcare Finland OyBZK2023-04-19
00840682146111CARESCAPE B650GE Healthcare Finland OyBZK2022-05-13
00840682146135CARESCAPE B450GE Healthcare Finland OyBZK2022-05-13
00840682146142CARESCAPE B850GE Healthcare Finland OyBZK2022-05-13
00840682104135NAGE Healthcare Finland OyBZK2022-03-07
00840682104302NAGE Healthcare Finland OyBZK2022-03-07
B005001460AincA®ANESTHESIA ASSOCIATES, INC.BZK2021-03-31
B005001470AincA®ANESTHESIA ASSOCIATES, INC.BZK2021-03-31
B005001490AincA®ANESTHESIA ASSOCIATES, INC.BZK2021-03-31
B005001930AincA®ANESTHESIA ASSOCIATES, INC.BZK2021-03-31
B005002900AincA®ANESTHESIA ASSOCIATES, INC.BZK2021-03-31
B005002940AincA®ANESTHESIA ASSOCIATES, INC.BZK2021-03-31
B005002950AincA®ANESTHESIA ASSOCIATES, INC.BZK2021-03-31
B005002960AincA®ANESTHESIA ASSOCIATES, INC.BZK2021-03-31
B005002980AincA®ANESTHESIA ASSOCIATES, INC.BZK2021-03-31
B005002990AincA®ANESTHESIA ASSOCIATES, INC.BZK2021-03-31
B005003010AincA®ANESTHESIA ASSOCIATES, INC.BZK2021-03-31
B005003020AincA®ANESTHESIA ASSOCIATES, INC.BZK2021-03-31
B005003030AincA®ANESTHESIA ASSOCIATES, INC.BZK2021-03-31
B005003050AincA®ANESTHESIA ASSOCIATES, INC.BZK2021-03-31
B005003060AincA®ANESTHESIA ASSOCIATES, INC.BZK2021-03-31
B00500306C0AincA®ANESTHESIA ASSOCIATES, INC.BZK2021-03-31