FDA.reportPublic FDA data

Sontek Medical

Primary DI
00859758005061
Brand
Sontek Medical
Company
NextPhase Medical Devices LLC
Model
A1003DHD
Device description
DHD Ported Swivel, Bulk
Published
2025-02-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZAConnector, Airway (Extension)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZAConnector, Airway (Extension)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859758005061PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859758005061008597580050618597580050610859758005061

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
PhoneEmail
508-261-0800lsampson@nextphasemed.com

Regulatory Flags#

DUNS number
072868941
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859758005009Sontek Medical A1002 Each2025-02-20
00859758005023Sontek Medical A1003 Each2025-02-20
00859758005030Sontek Medical A1002 Case 2025-02-20
00859758005047Sontek Medical A1003 Case2025-02-20
00859758005054Sontek Medical A1002N-S2025-02-20
10859758005006Sontek Medical A1002 Inner Pack 2025-02-20
10859758005020Sontek Medical A1003 Inner Pack 2025-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344214792HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-05-18
10197344009800HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-03-19
10197344012008HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
10197344012435HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
10197344012466HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
10197344012596HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
10197344042326HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
10889483225257AirLife™SUNMED, LLCBZA2025-12-22
10889483225226Adapters/ConnectorsSUNMED, LLCBZA2025-12-18
10889483225271AirLife™SUNMED, LLCBZA2025-12-18
10889483225660AirLife™SUNMED, LLCBZA2025-12-18
10197344012473HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2025-12-12
10197344042432HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2025-08-18
10884521854147DARCovidien LPBZA2025-08-10
10884521084995DARCovidien LPBZA2025-04-12
10884521842533DARCovidien LPBZA2025-04-12
10884522019743DARCovidien LPBZA2025-04-12
10884522019750DARCovidien LPBZA2025-04-12
10884522019774DARCovidien LPBZA2025-04-12
10884522019781DARCovidien LPBZA2025-04-12
10884522019804DARCovidien LPBZA2025-04-12
10884522019811DARCovidien LPBZA2025-04-12
10884522019828DARCovidien LPBZA2025-04-12
10884522019835DARCovidien LPBZA2025-04-12
10884522019842DARCovidien LPBZA2025-04-12
10884522019859DARCovidien LPBZA2025-04-12
10884522019866DARCovidien LPBZA2025-04-12
10884522019873DARCovidien LPBZA2025-04-12
10884522019880DARCovidien LPBZA2025-04-12
10884522019897DARCovidien LPBZA2025-04-12