FDA.reportPublic FDA data

Transcend

Primary DI
M950503120
Brand
Transcend
Company
SOMNETICS INTERNATIONAL, INC.
Model
AirFlex 6
Catalog number
503120
Published
2022-08-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
BYXTubing, Pressure And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYXTubing, Pressure And AccessoriesAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M950503120PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Inspiratory/expiratory limb respiratory tubing, single-useA length of tube made of durable materials (e.g., rubber, silicone) intended to be used to conduct breathing gases towards or away from a patient during the respiratory cycle, typically during anaesthesia or ventilation [including continuous or bi-level positive airway pressure ventilation (CPAP or BPAP)]. It is intended to function as part of a breathing circuit and with other separate gas delivery devices (e.g., respiratory mask, connectors). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8776219626info@mytranscend.com

Regulatory Flags#

DUNS number
047069263
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M9505050340TranscendMicro WhisperSoft Muffler - S5050342024-01-31
M9505050010TranscendMicro PowerAway Battery5050012024-01-31
M9505050170TranscendMicro PureFresh5050172024-01-31
M9505050330TranscendMicro WhisperSoft Muffler - C5050332024-01-31
M9505060010TranscendMicro CPAP5060012023-08-22
M950503119TranscendAirFlex 45031192022-08-03
M950503121TranscendWhisperSoft 45031212022-08-03
M950503122TranscendWhisperSoft 65031222022-08-03
M950503123TranscendWhisperSoft 45031232022-08-03
M950503124TranscendWhisperSoft 65031242022-08-03
M950505002TranscendWhisperSoft5050022022-08-03
M950505003TranscendWhisperSoft Micro5050032022-08-03
M950505004TranscendAirFlex Micro 65050042022-08-03
M950505025TranscendWhisperSoft Micro 45050252022-08-03
M950505026TranscendWhisperSoft Micro 65050262022-08-03
M950505027TranscendAirFlex Micro 45050272022-08-03
M950505028TranscendWhisperSoft Micro 45050282022-08-03
M950505029TranscendWhisperSoft Micro 65050292022-08-03
M9505030230TranscendP8 Battery5030232019-01-03
M9505030260TranscendP4 Battery5030262019-01-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00607411919220Salter Labs® Oxygen TubingSALTER LABSBYX2026-06-09
00607411919237Salter Labs® Oxygen TubingSALTER LABSBYX2026-06-09
00607411919244Salter Labs® Oxygen TubingSALTER LABSBYX2026-06-09
00607411919251Salter Labs® Oxygen Tubing (MedTronic)SALTER LABSBYX2026-06-09
B929C4NI024FNNFP40Western Enterprises, IncWestern EnterprisesBYX2026-06-04
B929N4AIK240FHTFP40Western Enterprises, IncWestern EnterprisesBYX2026-06-04
B929N4OXW240FHTFP40Western Enterprises, IncWestern EnterprisesBYX2026-06-04
00848530108328Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.BYX2026-06-03
00848530108953Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.BYX2026-06-02
00848530108960Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.BYX2026-06-02
00848530108977Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.BYX2026-06-02
00848530109011Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.BYX2026-06-02
00848530109028Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.BYX2026-06-02
00848530109035Repair PartSUNSET HEALTHCARE SOLUTIONS, INC.BYX2026-06-02
00848530109073Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.BYX2026-06-02
10197344011230HUDSON RCIMEDLINE INDUSTRIES, INC.BYX2026-02-13
10197344011155HUDSON RCIMEDLINE INDUSTRIES, INC.BYX2026-02-12
10197344042401HUDSON RCIMEDLINE INDUSTRIES, INC.BYX2026-02-12
10885632467431HalyardOWENS & MINOR DISTRIBUTION, INC.BYX2026-01-29
10889483234402curaplex®SUNMED, LLCBYX2025-12-31
10889483225639AirLife™SUNMED, LLCBYX2025-12-18
10889483229279AirLife™SUNMED, LLCBYX2025-12-18
10197344162710MEDLINEMEDLINE INDUSTRIES, INC.BYX2025-12-12
10197344162727MEDLINEMEDLINE INDUSTRIES, INC.BYX2025-12-12
10197344011780HUDSON RCIMEDLINE INDUSTRIES, INC.BYX2025-12-03
10197344012237HUDSON RCIMEDLINE INDUSTRIES, INC.BYX2025-12-03
10197344012244HUDSON RCIMEDLINE INDUSTRIES, INC.BYX2025-12-03
10197344012572HUDSON RCIMEDLINE INDUSTRIES, INC.BYX2025-12-03
10197344042258HUDSON RCIMEDLINE INDUSTRIES, INC.BYX2025-12-03
10197344165315MEDLINEMEDLINE INDUSTRIES, INC.BYX2025-09-26