FDA.report

AincA®

Primary DI
B005E1910
Brand
AincA®
Company
ANESTHESIA ASSOCIATES, INC.
Model
E-191
Catalog number
E-191
Device description
Bag, Breathing, FLUTED, 15mmF SS Bushing, 500cc, Black Conductive Neoprene
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

Product Codes

CodeName
BTCBAG, RESERVOIR

Product Code Classifications

CodeDeviceSpecialtyClass
BTCBag, ReservoirAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B005E1910PrimaryHIBCC0

GMDN Terms

TermDefinition
Breathing circuit bag, reusableA non-sterile elastomeric reservoir sac intended to store breathing gas during the respiratory cycle. The breathing bag may be on the inspiratory or expiratory limb of a breathing circuit depending on the breathing circuit design. It may also function as a maximum pressure limiting device during spontaneous or manually assisted ventilation. It may be made of conductive or non-conductive material and is typically used in anaesthesia or ventilator breathing circuits. This is a reusable device.

Device Sizes

TypeValueUnit
Total Volume0.5Liter

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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B005LF715500AincA®LF-715-50LF-715-502023-08-17

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