FDA.reportPublic FDA data

AincA®

Primary DI
B005001150
Brand
AincA®
Company
ANESTHESIA ASSOCIATES, INC.
Model
00-115
Catalog number
00-115
Device description
Arm, Universal Control, Single Tube System, Gauge, Bag Nipple, 22mmMx15mmF Outlet, w/00-113 APL Valve
Published
2021-03-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CAICircuit, breathing (w connector, adaptor, y piece)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)Anesthesiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K833871000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K833871000UNIVERSAL CONTROL ARMAnesthesia Assoc., Inc.1983-12-27CAI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B005001150PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia breathing circuit, reusableA non-sterile assembly of devices designed to conduct medical gases from the fresh gas supply outlet of an anaesthesia unit/workstation to the patient typically connecting the patient, a ventilator/ventilation bag, carbon dioxide (CO2) absorber, and a monitor. It typically includes both an inhalation and exhalation route and consists of breathing tubes, a ventilation and/or reservoir bag(s), a Y-piece, connectors/adaptors, and gas sampling ports. The absorber, a one-way directional valve, and adjustable pressure limiting (APL) valve are also devices typically employed in the circuit but may not be a part of this device. It may be conductive or non-conductive. 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
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

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Primary DI, Brand, Company table
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06923980116209N/AGaleMed Xiamen Co., Ltd.CAI2026-08-19
0503026717028922MM SMOOTHBORE BILEVEL BREATHING SYSTEM FOR NKV-330 WITH MONIT. LINEIntersurgical IncorporatedCAI2026-08-18
14896138016692inspired™VINCENT MEDICAL MANUFACTURING CO., LIMITEDCAI2026-08-05
04719874956547Create BiotechCREATE BIOTECH CO., LTD.CAI2026-07-16
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10889483592175Vital Signs™AIRLIFECAI2025-02-11
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