FDA.reportPublic FDA data

AincA®

Primary DI
B005LF619500
Brand
AincA®
Company
ANESTHESIA ASSOCIATES, INC.
Model
LF-619-50
Catalog number
LF-619-50
Device description
Bag, Breathing, FLAT, 19mmF Rubber Bushing, 5 Liter, Black Neoprene
Published
2023-08-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTCBAG, RESERVOIR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTCBag, ReservoirAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B005LF619500PrimaryHIBCC0

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Total Volume5Liter

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
04816415501430BREATHING BAG single use 500ASSOMEDIKA, OOOBTC2026-05-27
04816415501447BREATHING BAG single use 1000ASSOMEDIKA, OOOBTC2026-05-27
04816415501454BREATHING BAG single use 2000ASSOMEDIKA, OOOBTC2026-05-27
04816415501461BREATHING BAG single use 3000ASSOMEDIKA, OOOBTC2026-05-27
04816415501478BREATHING BAG reusable 500ASSOMEDIKA, OOOBTC2026-05-27
04816415501485BREATHING BAG reusable 1000ASSOMEDIKA, OOOBTC2026-05-27
04816415501492BREATHING BAG reusable 2000ASSOMEDIKA, OOOBTC2026-05-27
04816415501508BREATHING BAG reusable 3000ASSOMEDIKA, OOOBTC2026-05-27
08697645018198ENDURE INDUSTRIESENDURE INDUSTRIESBTC2026-04-17
10885632455438Halyard Breathing BagAIRLIFEBTC2025-07-25
10885632455414Halyard Breathing BagAIRLIFEBTC2025-07-18
10885632455421Halyard Breathing BagAIRLIFEBTC2025-07-18
10629160000346FEATHER-FLEXBOMImed IncBTC2025-07-14
10629160000339FEATHER-FLEXBOMImed IncBTC2024-03-01
10080196984190Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
10080196984213Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
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10080196984848Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
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10080196984916Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
10080196984930Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
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10884389447048Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
10884389447093Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04