FDA.report

Vital Signs™

Primary DI
30889483584808
Brand
Vital Signs™
Company
Sunmed Group Holdings, LLC
Model
5062ABS
Catalog number
5062ABS
Device description
Vital Signs™ Adult Anesthesia Breathing Circuit
Published
2025-03-06
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
BTCBag, Reservoir

Product Code Classifications

CodeDeviceSpecialtyClass
BTCBag, ReservoirAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30889483584808PackageGS120In Commercial Distribution
10889483584804PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3088948358480830889483584808
1088948358480410889483584804

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.

Device Sizes

TypeValueUnit
Length40Inch

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
119058668
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
30889483569522AirLife™001248U001248U2025-03-28
30889483570566AirLife™0018000018002025-03-28
30889483571914AirLife™0081780081782025-03-28
30889483570474AirLife™0016080016082025-03-27
30889483570559AirLife™0017970017972025-03-27
30889483570573AirLife™0018010018012025-03-27
30889483570597AirLife™0018030018032025-03-27
30889483570603AirLife™0018100018102025-03-27
30889483570658AirLife™0018220018222025-03-27
30889483570665AirLife™0018230018232025-03-27
30889483570672AirLife™0018240018242025-03-27
30889483570689AirLife™0018300018302025-03-27
30889483570863AirLife™0019510019512025-03-27
30889483570887AirLife™0019550019552025-03-27
30889483571679AirLife™0037600037602025-03-27
30889483571686AirLife™0037620037622025-03-27
30889483571693AirLife™0037640037642025-03-27
30889483572119AirLife™0P17750P17752025-03-27
30889483572126AirLife™0P17760P17762025-03-27
30889483572164AirLife™0Y37700Y37702025-03-27

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
06923980111907MindrayGaleMed Xiamen Co., Ltd.BTC2026-05-26
06923980112614MindrayGaleMed Xiamen Co., Ltd.BTC2026-05-26
06923980112621MindrayGaleMed Xiamen Co., Ltd.BTC2026-05-26
06923980112638MindrayGaleMed Xiamen Co., Ltd.BTC2026-05-26
06923980112805MindrayGaleMed Xiamen Co., Ltd.BTC2026-05-26
06923980112829MindrayGaleMed Xiamen Co., Ltd.BTC2026-05-26
20889483560959Vital Signs™SUNMED, LLCBTC2025-12-31
20889483560942Vital Signs™SUNMED, LLCBTC2025-12-30
20889483560935Vital Signs™SUNMED, LLCBTC2025-12-19
20885632455435Halyard Breathing BagAIRLIFEBTC2025-07-25
20885632455411Halyard Breathing BagAIRLIFEBTC2025-07-18
20885632455428Halyard Breathing BagAIRLIFEBTC2025-07-18
10889483642412Vital Signs Breathing BagAIRLIFEBTC2025-07-18
10889483642429Vital Signs Breathing BagAIRLIFEBTC2025-07-18
10889483642436Vital Signs Breathing BagAIRLIFEBTC2025-07-18
10889483642443Vital Signs Breathing BagAIRLIFEBTC2025-07-18
20629160000350FEATHER-FLEXBOMImed IncBTC2025-07-14
46923980115552MindrayGaleMed Xiamen Co., Ltd.BTC2025-06-23
10889483602492Vital Signs™AirLife Finland OyBTC2025-04-04
20889483601706Vital Signs™AirLife Finland OyBTC2025-04-01
20889483601713Vital Signs™AirLife Finland OyBTC2025-04-01
20889483601720Vital Signs™AirLife Finland OyBTC2025-04-01
20889483601737Vital Signs™AirLife Finland OyBTC2025-04-01
20889483620073Vital Signs™AirLife Finland OyBTC2025-04-01
20889483602505Vital Signs™AirLife Finland OyBTC2025-03-28
20889483602512Vital Signs™AirLife Finland OyBTC2025-03-28
30889483584822Vital Signs™Sunmed Group Holdings, LLCBTC2025-03-06
06972249260085Breathing bagsShandong Jinlai Huanhai Medical Technology Co., Ltd.BTC2025-03-03
06972249260092Breathing bagsShandong Jinlai Huanhai Medical Technology Co., Ltd.BTC2025-03-03
06972249260108Breathing bagsShandong Jinlai Huanhai Medical Technology Co., Ltd.BTC2025-03-03