FDA.reportPublic FDA data

BiPAP A40 EFL

Primary DI
00606959005211
Brand
BiPAP A40 EFL
Company
Respironics, Inc.
Model
Trilogy Active Flow Exhalation Circuit, Adult
Catalog number
1068837
Device description
Trilogy Ventilator - Active Flow Exhalation Patient Circuit, Adult
Published
2016-09-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CBKVENTILATOR, CONTINUOUS, FACILITY USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBKVentilator, Continuous, Facility UseAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K083526000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083526000TRILOGY 100 VENTILATORRespironics Inc., Sleep & Home Respiratory Group2009-03-13CBK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00606959005211PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00606959005211006069590052116069590052110606959005211

GMDN Terms#

Term, Definition table
TermDefinition
Ventilator breathing circuit, reusableAn assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator, or other air-delivery therapeutic device such as a mechanical insufflator/exsufflator, to a patient. It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius
Storage Environment Temperature-4 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(724) 387-4000respironics.service@philips.com

Regulatory Flags#

DUNS number
080728314
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00606959055735Sleepware G3 Sleepware G3 2026-01-22
00606959060586Care OrchestratorCare Orchestrator2026-01-22
00606959424852DreamStation BiPAP autoSVDreamStation BiPAP autoSV w/Humid w/H tube w/Cell,AUX900T15C2017-02-01
00606959424944DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 AE w/Humidifier w/Cell,AUX1131H15C2017-02-10
00606959424951DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 AE w/Cell, AUAUX1131S15C2017-02-10
00606959424968DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 AE w/Humd w/H Tube w/CeAUX1131T15C2017-02-10
00606959424975DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 AE w/Humidifier w/WiFi,AUX1131H15W2017-02-10
00606959424982DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 AE w/WiFi, AUAUX1131S15W2017-02-10
00606959424999DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 AE w/Humid w/H Tube w/WAUX1131T15W2017-02-10
00606959425378DreamStation01CNX1130T172019-12-29
00606959425385DreamStation01CNX1131H172019-12-29
00606959425392DreamStation01CNX1131S172019-12-29
00606959425408DreamStation01CNX1131T172019-11-20
00606959425484DreamStation BiPAP autoSVDreamStation BiPAP autoSV w/Humid w/H Tube, w/CellCAX900T12C2017-02-01
00606959425491DreamStation BiPAP autoSVDreamStation BiPAP autoSV w/Humid w/H Tube, w/WiFiCAX900T12W2017-02-01
00606959425538DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 w/Humidifier w/Cell, CACAX1130H12C2017-02-10
00606959425545DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 w/Cell, CACAX1130S12C2017-02-10
00606959425552DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 w/Humid w/H Tube w/CellCAX1130T12C2017-02-10
00606959425569DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 w/Humidifier w/WiFi, CACAX1130H12W2017-02-10
00606959425576DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 w/WiFi, CACAX1130S12W2017-02-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344102655MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
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10197344102693MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
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09420012480484F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
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