FDA.report

Vital Signs™

Primary DI
20889483602444
Brand
Vital Signs™
Company
AirLife Finland Oy
Model
M1036379
Catalog number
M1036379
Device description
Vital Signs™ Patient Circuit Tube on the Roll, Adult, Disposable 30 m/ 1200 in
Published
2025-03-28
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
true

Related Records

Contact Domains

Product Codes

CodeName
BYXTubing, Pressure And Accessories

Product Code Classifications

CodeDeviceSpecialtyClass
BYXTubing, Pressure And AccessoriesAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20889483602444PackageGS120In Commercial Distribution
10190752108882PreviousGS10
10889483602447PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2088948360244420889483602444
1019075210888210190752108882
1088948360244710889483602447

GMDN Terms

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.

Sterilization Methods

Method

Contacts

PhoneEmail
(800)433-2797info@sun-med.com

Regulatory Flags

DUNS number
368457563
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
10889483575901Multi-Link™2017005-0032017005-0032025-04-22
20889483576493Vital Signs™2030887-0012030887-0012025-04-22
20889483576707Multi-Link™2052104-0082052104-0082025-04-22
20889483578671Vital Signs™22616605226166052025-04-22
20889483578695Vital Signs™22616611226166112025-04-22
20889483578701Vital Signs™22616702226167022025-04-22
20889483583361Medisorb™4270001004270001002025-04-22
20889483589929Medisorb™800313880031382025-04-22
20889483590529Medisorb™857004385700432025-04-22
20889483602833Vital Signs™M1087562M10875622025-04-22
20889483603359Vital Signs™M1154610M11546102025-04-22
20889483576554Vital Signs™2036970-0012036970-0012025-04-17
20889483602918AirLife™M1093120M10931202025-04-17
20889483602925AirLife™M1093121M10931212025-04-17
20889483602932AirLife™M1093122M10931222025-04-17
20889483602949AirLife™M1093123M10931232025-04-17
20889483603038AirLife™M1097108M10971082025-04-17
20889483603045AirLife™M1097109M10971092025-04-17
10889483583388Vital Signs™4270107004270107002025-04-14
10889483587072Vital Signs™5870402005870402002025-04-14

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00628101548254OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101559618OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101595708OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101599980OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101622374OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631543OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631567OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631574OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631628OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631635OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631642OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631673OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631680OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631703OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631710OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631727OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631734OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631741OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631758OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631802OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631819OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631826OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631833OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631871OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631888OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631918OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631925OhioOHIO MEDICAL, LLCBYX2026-03-23
00628101631932OhioOHIO MEDICAL, LLCBYX2026-03-23
00628101631949OhioOHIO MEDICAL, LLCBYX2026-03-23
00848530108632CPAP TubingSUNSET HEALTHCARE SOLUTIONS, INC.BYX2026-03-19