FDA.report

AincA®

Primary DI
B005007200
Brand
AincA®
Company
ANESTHESIA ASSOCIATES, INC.
Model
00-720
Catalog number
00-720
Device description
CO2 Absorber, Pediatric, w/Directional & Scavenging Valves, Pressure Manometer, 1Canister 1200cc
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
BSFABSORBER, CARBON-DIOXIDE

Product Code Classifications

CodeDeviceSpecialtyClass
BSFAbsorber, Carbon-DioxideAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B005007200PrimaryHIBCC0

GMDN Terms

TermDefinition
Anaesthetic gas absorption/desorption deviceA non-sterile device intended to, when integrated within the common line of a breathing circuit (open or partial rebreathing), absorb and desorb (i.e., recycle) exhaled volatile anaesthetic agents; it may also be used to facilitate monitoring (e.g., gas concentration and pressure, breathing activity) via connection to breathing system components. It is typically a housing containing an anaesthetic gas absorption/desorption filter, and may include sensors. This is a reusable device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
002065670
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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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