FDA.report

Vital Signs™

Primary DI
20889483603113
Brand
Vital Signs™
Company
AirLife Finland Oy
Model
M1128262
Catalog number
M1128262
Device description
Vital Signs™ Manual Ventilation Tube for ABS Bag Arm, Disposable, 0.9 m/36 in With ABS Bag Arm Connector
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
20889483603113PackageGS120In Commercial Distribution
10190752136786PreviousGS10
10889483603116PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2088948360311320889483603113
1019075213678610190752136786
1088948360311610889483603116

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

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