FDA.report

Vital Signs™

Primary DI
30889483595668
Brand
Vital Signs™
Company
Sunmed Group Holdings, LLC
Model
AGNX204X
Catalog number
AGNX204X
Device description
Vital Signs™ Limb-O™ Single Limb Anesthesia Breathing Circuit
Published
2025-02-14
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
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)

Product Code Classifications

CodeDeviceSpecialtyClass
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)Anesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30889483595668PackageGS120In Commercial Distribution
10190752122697PreviousGS10
10889483595664PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3088948359566830889483595668
1019075212269710190752122697
1088948359566410889483595664

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
119058668
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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
44710810083325N/AGALEMED CORPORATIONCAI2026-03-05
44710810085558N/AGALEMED CORPORATIONCAI2026-03-05
44710810087682N/AGALEMED CORPORATIONCAI2026-03-05
44710810088559N/AGALEMED CORPORATIONCAI2026-03-05
44710810101319N/AGALEMED CORPORATIONCAI2026-03-05
44710810103504N/AGALEMED CORPORATIONCAI2026-03-05
44710810105720N/AGALEMED CORPORATIONCAI2026-03-05
44710810105737N/AGALEMED CORPORATIONCAI2026-03-05
44710810110915N/AGALEMED CORPORATIONCAI2026-03-05
44710810116108N/AGALEMED CORPORATIONCAI2026-03-05
44710810080867N/AGALEMED CORPORATIONCAI2026-03-04
44710810087859N/AGALEMED CORPORATIONCAI2026-03-04
44710810088474N/AGALEMED CORPORATIONCAI2026-03-04
44710810089808N/AGALEMED CORPORATIONCAI2026-03-04
44710810103146N/AGALEMED CORPORATIONCAI2026-03-04
44710810114098N/AGALEMED CORPORATIONCAI2026-03-04
44710810116092N/AGALEMED CORPORATIONCAI2026-03-04
44710810116924N/AGALEMED CORPORATIONCAI2026-03-04
20889483300135Respan®SUNMED, LLCCAI2026-02-11
46923980110359N/AGaleMed Xiamen Co., Ltd.CAI2026-02-05
M368H0678972HAUSTEDGF HEALTH PRODUCTS, INC.CAI2025-10-31
00612649214559UNIVERSAL F® FLEX2®King Systems CorporationCAI2023-01-18
00612649130972JACKSON REESKing Systems CorporationCAI2023-01-18
00612649214047UNIVERSAL F® FLEX2®King Systems CorporationCAI2023-01-18
00612649214030UNIVERSAL F® FLEX2®King Systems CorporationCAI2023-01-18
00612649214078UNIVERSAL F® FLEX2®King Systems CorporationCAI2023-01-18
00612649214092UNIVERSAL F® FLEX2®King Systems CorporationCAI2023-01-18
00612649214115UNIVERSAL F® FLEX2®King Systems CorporationCAI2023-01-18
00612649214139UNIVERSAL F® FLEX2®King Systems CorporationCAI2023-01-18
00612649214153UNIVERSAL F® FLEX2®King Systems CorporationCAI2023-01-18