FDA.report

AincA®

Primary DI
B005003050
Brand
AincA®
Company
ANESTHESIA ASSOCIATES, INC.
Model
00-305
Catalog number
00-305
Device description
Respirometer, Analog, Safety Harness w/Strap
Published
2021-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
BZKSpirometer, monitoring (w/wo alarm)

Product Code Classifications

CodeDeviceSpecialtyClass
BZKSpirometer, Monitoring (W/Wo Alarm)Anesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B005003050PrimaryHIBCC0

GMDN Terms

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

Contacts

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

Regulatory Flags

DUNS number
002065670
Device count
1
DM exempt
true
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

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B005LF619400AincA®LF-619-40LF-619-402023-08-17
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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

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00884838015616NM3 Monitor, DutchRESPIRONICS NOVAMETRIX, LLCBZK2016-09-22
00884838015630NM3 Monitor, FrenchRESPIRONICS NOVAMETRIX, LLCBZK2016-09-22
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