FDA.report

Vital Signs™

Primary DI
20889483602376
Brand
Vital Signs™
Company
AirLife Finland Oy
Model
M1036006
Catalog number
M1036006
Device description
Vital Signs™ Catheter Mount, Disposable With Expandable Memoflex, (15mmF-22mmF), 150mm and Elbow
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
BZAConnector, Airway (Extension)

Product Code Classifications

CodeDeviceSpecialtyClass
BZAConnector, Airway (Extension)Anesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20889483602376PackageGS150In Commercial Distribution
10190752139541PreviousGS10
10889483602379PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2088948360237620889483602376
1019075213954110190752139541
1088948360237910889483602379

GMDN Terms

TermDefinition
Breathing circuit catheter mount, single-useA device designed to connect a respiratory circuit (e.g., an anaesthesia breathing circuit or ventilator breathing circuit) or a resuscitator to an endotracheal (ET) tube, to enable increased mobility at the patient end of the circuit or connections. It most commonly consists of a 22 mm female adaptor at the proximal end that is attached to a short length of corrugated, flexible tube (e.g., 150 mm long), and a straight or angled 15 mm male connector at the distal end; it may include an integrated suction port or be provided with a microbial medical gas filter. 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
06923980112799MindrayGaleMed Xiamen Co., Ltd.BZA2026-05-26
06944904007236MindrayGaleMed Xiamen Co., Ltd.BZA2026-05-26
16923980103206N/AGaleMed Xiamen Co., Ltd.BZA2026-05-25
20197344009807HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-03-19
44710810084858N/AGALEMED CORPORATIONBZA2026-03-05
44710810086548N/AGALEMED CORPORATIONBZA2026-03-05
44710810102453N/AGALEMED CORPORATIONBZA2026-03-05
44710810104037N/AGALEMED CORPORATIONBZA2026-03-05
44710810110731N/AGALEMED CORPORATIONBZA2026-03-05
44710810082601N/AGALEMED CORPORATIONBZA2026-03-04
44710810083929N/AGALEMED CORPORATIONBZA2026-03-04
44710810086753N/AGALEMED CORPORATIONBZA2026-03-04
44710810087187N/AGALEMED CORPORATIONBZA2026-03-04
44710810104563N/AGALEMED CORPORATIONBZA2026-03-04
44710810107328N/AGALEMED CORPORATIONBZA2026-03-04
44710810111417N/AGALEMED CORPORATIONBZA2026-03-04
44710810115941N/AGALEMED CORPORATIONBZA2026-03-04
00619498004409HumidAirRESMED PTY LTDBZA2026-02-09
04048675034643Connector M34X1.5, 9/16Drägerwerk AG & Co. KGaABZA2026-02-04
04048675034735Adapter 9/16" to 6mmDrägerwerk AG & Co. KGaABZA2026-02-04
20197344012005HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
20197344012432HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
20197344012463HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
20197344012593HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
20197344042323HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
46923980107748N/AGaleMed Xiamen Co., Ltd.BZA2025-12-24
46923980107281N/AGaleMed Xiamen Co., Ltd.BZA2025-12-23
20889483225254AirLife™SUNMED, LLCBZA2025-12-22
20889483225223Adapters/ConnectorsSUNMED, LLCBZA2025-12-18
20889483225278AirLife™SUNMED, LLCBZA2025-12-18