FDA.reportPublic FDA data

AincA®

Primary DI
B005003890
Brand
AincA®
Company
ANESTHESIA ASSOCIATES, INC.
Model
00-389
Catalog number
00-389
Device description
"Valve, Bag-Tail Hand Adjustable, 3/8"" Nipple x 22mmM/19mmF Suction w/Neg Relief, Aluminum/Plastic"
Published
2021-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JFEVALVE, SWITCHING (PLOSS)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JFEValve, Switching (Ploss)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B005003890PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Ventilator converterA device intended to be used to couple together any type of powered ventilator to any kind of breathing circuit system, making them compatible for use. By using this device it is then possible to use alternative combinations of ventilator and breathing circuit from different manufacturers. This will assist, e.g., a hospital to be flexible in the choice of breathing circuit or system and allowing for the introduction to new kinds whilst the ventilators may remain the same. 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
B005001160AincA®ANESTHESIA ASSOCIATES, INC.JFE2021-03-31
B005003860AincA®ANESTHESIA ASSOCIATES, INC.JFE2021-03-31
B005003870AincA®ANESTHESIA ASSOCIATES, INC.JFE2021-03-31
B00500387D320250AincA®ANESTHESIA ASSOCIATES, INC.JFE2021-03-31
00855887006917Dial FlowmeterPrecision Medical, Inc.JFE2020-03-25
00855887006863Dial FlowmeterPrecision Medical, Inc.JFE2018-04-05