FDA.reportPublic FDA data

Vital Signs™

Primary DI
10889483601723
Brand
Vital Signs™
Company
AirLife Finland Oy
Model
M1019521
Catalog number
M1019521
Device description
Vital Signs™ Manual Ventilation Components, Disposable 1.8 m/72 in, With Manual Bag, 2 L
Published
2025-04-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
20889483601720PackageGS120In Commercial Distribution
10190752136151PreviousGS10
10889483601723PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088948360172020889483601720
1019075213615110190752136151
1088948360172310889483601723

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia breathing circuit, single-useAn assembly of devices designed to conduct medical gases from an anaesthesia unit/workstation to a patient artificial airway/anaesthesia mask (not included) during general anaesthesia. It includes breathing tubes and a Y-piece connector, typically with a ventilator/ventilation bag and appropriate connectors, and may include a carbon dioxide (CO2) absorber, a one-way directional valve, or adjustable pressure limiting (APL) valve. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
(800)433-2797info@sun-med.com

Regulatory Flags#

DUNS number
368457563
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10190752140912Vital Signs™M1031274M10312742021-01-28
10190752145641Vital Signs™M1031273M10312732021-07-06
10190752191235Vital Signs™M1031274M10312742023-05-30
10190752125582Vital Signs™2025248-0012025248-0012018-11-23
10190752125599Vital Signs™2025248-0022025248-0022018-11-23
10190752125629Vital Signs™9446-9119446-9112018-11-23
10190752125636Vital Signs™9446-9139446-9132018-11-23
10190752181380Vital Signs™9446-9119446-9112020-12-15
10190752181397Vital Signs™9446-9139446-9132020-12-15
10190752179349Vital Signs™2025248-0012025248-0012020-12-01
10190752179356Vital Signs™2025248-0022025248-0022020-12-01
10889483587881AirLife™6600-0196-7006600-0196-7002025-03-26
10889483587904AirLife™6600-0208-7006600-0208-7002025-03-26
10889483590003AirLife™800423180042312025-04-02
10889483590584AirLife™857020385702032025-04-02
10889483601563AirLife™M1010534M10105342025-04-02
10889483602522AirLife™M1038637M10386372025-03-31
10889483603222Vital Signs™M1138830M11388302025-04-02
10889483586549AirLife™5570195005570195002025-04-02
10889483586624AirLife™5570701005570701002025-04-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08697645018198ENDURE INDUSTRIESENDURE INDUSTRIESBTC2026-04-17
10889483560952Vital Signs™SUNMED, LLCBTC2025-12-31
10889483560945Vital Signs™SUNMED, LLCBTC2025-12-30
10889483560938Vital Signs™SUNMED, LLCBTC2025-12-19
10885632455438Halyard Breathing BagAIRLIFEBTC2025-07-25
10885632455414Halyard Breathing BagAIRLIFEBTC2025-07-18
10885632455421Halyard Breathing BagAIRLIFEBTC2025-07-18
10629160000346FEATHER-FLEXBOMImed IncBTC2025-07-14
10889483601709Vital Signs™AirLife Finland OyBTC2025-04-01
10889483601716Vital Signs™AirLife Finland OyBTC2025-04-01
10889483601730Vital Signs™AirLife Finland OyBTC2025-04-01
10889483584804Vital Signs™AIRLIFEBTC2025-03-06
10889483584828Vital Signs™AIRLIFEBTC2025-03-06
10629160000339FEATHER-FLEXBOMImed IncBTC2024-03-01
10080196984190Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
10080196984213Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
10080196984251Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
10080196984770Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
10080196984787Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
10080196984848Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
10080196984855Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
10080196984916Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
10080196984930Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
10884389001943Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
10884389004999Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
10884389005002Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
10884389380932Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
10884389382615Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
10884389447048Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04
10884389447093Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTC2022-08-04