FDA.report

Vital Signs™

Primary DI
30889483595149
Brand
Vital Signs™
Company
Sunmed Group Holdings, LLC
Model
AFNXXXX4PX6
Catalog number
AFNXXXX4PX6
Device description
Limb-O™ Single Limb Anesthesia Breathing Circuit
Published
2025-02-18
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
OFPAnesthesia Breathing Circuit Kit (Adult & Pediatric)

Product Code Classifications

CodeDeviceSpecialtyClass
OFPAnesthesia Breathing Circuit Kit (Adult & Pediatric)Anesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30889483595149PackageGS120In Commercial Distribution
10190752152250PreviousGS10
10889483595145PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3088948359514930889483595149
1019075215225010190752152250
1088948359514510889483595145

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
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
00850070635035Breathing Circuit KitNar Medical Depot, LLCOFP2025-12-01
50198956137248CARDINAL HEALTHCardinal Health 200, LLCOFP2025-08-11
04048675695622Anesthesia Circuit Kit Coax HEPADrägerwerk AG & Co. KGaAOFP2025-05-19
04048675695639Anesthesia Circuit Kit Flex HEPADrägerwerk AG & Co. KGaAOFP2025-05-19
0503026716154622mm Compact breathing systemIntersurgical IncorporatedOFP2025-04-14
0503026716175122mm Compact breathing systemIntersurgical IncorporatedOFP2025-04-14
10889483583388Vital Signs™AirLife Finland OyOFP2025-04-14
10889483587072Vital Signs™AirLife Finland OyOFP2025-04-14
10889483587089Vital Signs™AirLife Finland OyOFP2025-04-14
10889483587096Vital Signs™AirLife Finland OyOFP2025-04-14
10889483587102Vital Signs™AirLife Finland OyOFP2025-04-14
10889483587119Vital Signs™AirLife Finland OyOFP2025-04-14
10889483587126Vital Signs™AirLife Finland OyOFP2025-04-14
10889483590072Vital Signs™AirLife Finland OyOFP2025-04-14
00816472022972Multipac UniFlow anesthesia breathing systemIntersurgical IncorporatedOFP2025-04-11
10841470106215ABC -Flex Tube SystemENGINEERED MEDICAL SYSTEMS INCOFP2025-04-11
10841470106260ABC - Uniflow Breathing CircuitENGINEERED MEDICAL SYSTEMS INCOFP2025-04-11
10841470106284ABC - Duoflow Bi-lumen Breathing CircuitENGINEERED MEDICAL SYSTEMS INCOFP2025-04-11
10841470106345ABC - Flex Tube SystemENGINEERED MEDICAL SYSTEMS INCOFP2025-04-11
10841470106574ABC - Compact Breathing CircuitENGINEERED MEDICAL SYSTEMS INCOFP2025-04-11
10841470106581ABC - Compact Breathing CircuitENGINEERED MEDICAL SYSTEMS INCOFP2025-04-11
10841470106734ABC - Duoflow Bi-lumen Breathing CircuitENGINEERED MEDICAL SYSTEMS INCOFP2025-04-11
10841470107113ABC - Uniflow Breathing CircuitENGINEERED MEDICAL SYSTEMS INCOFP2025-04-11
10841470107656ABC - Uniflow Breathing CircuitENGINEERED MEDICAL SYSTEMS INCOFP2025-04-11
10841470108622ABC - Flex Tube SystemENGINEERED MEDICAL SYSTEMS INCOFP2025-04-11
10841470108738ABC - Duoflow Bi-lumen Breathing CircuitENGINEERED MEDICAL SYSTEMS INCOFP2025-04-11
10841470108844ABC - Pediatric Compact Breathing CircuitENGINEERED MEDICAL SYSTEMS INCOFP2025-04-11
10841470108943ABC - Duoflow Bi-lumen Breathing CircuitENGINEERED MEDICAL SYSTEMS INCOFP2025-04-11
10841470108950ABC - Pediatric Compact Breathing CircuitENGINEERED MEDICAL SYSTEMS INCOFP2025-04-11
10841470109452ABC - Compact Breathing CircuitENGINEERED MEDICAL SYSTEMS INCOFP2025-04-11