FDA.reportPublic FDA data

ARC Medical

Primary DI
00810050853927
Brand
ARC Medical
Company
TYPENEX MEDICAL LLC
Model
5010F
Device description
Poppel Flex
Published
2021-08-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
10810050853924PackageGS150In Commercial Distribution
00810050853927PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081005085392410810050853924
00810050853927008100508539278100508539270810050853927

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia breathing circuit, reusableAn 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 reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature5 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
312-888-4064mchoquette@typenex.com

Regulatory Flags#

DUNS number
600850213
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810050851954Typenex Introducer SetMS17122020-06-09
00810050853460Typenex Introducer SetMS1235S2021-01-26
00810050853491Typenex Introducer SetMS1335S2021-01-26
00810050853514Typenex Introducer SetMS1835S2021-01-26
00810050853774Typenex Introducer SetMS19122021-08-11
00810050853804Typenex Introducer SetMS21122021-08-11
00810050853811Typenex Introducer SetMS20122021-08-11
00810050853842Typenex Introducer SetMS22122021-08-11
00810050855808Typenex Introducer SetMS2335S2025-11-17
00812269032957Typenex Introducer SetMS02362019-09-18
00812269032971Typenex Introducer SetMS03362019-09-18
00812269032995Typenex Introducer SetMS04362019-09-18
00812269033015Typenex Introducer SetMS05362019-09-18
00812269033039Typenex Introducer SetMS06362019-09-18
00812269033053Typenex Introducer SetMS02442019-09-18
00812269033077Typenex Introducer SetMS03442019-09-18
00812269033091Typenex Introducer SetMS04442019-09-18
00812269033114Typenex Introducer SetMS1144S2019-09-18
00812269033138Typenex Introducer SetMS1244S2019-09-18
00812269033152Typenex Introducer SetMS1344S2019-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00628101633028OhioOHIO MEDICAL, LLCBYX2026-10-26
00628101633035OhioOHIO MEDICAL, LLCBYX2026-10-26
00628101633479OhioOHIO MEDICAL, LLCBYX2026-10-26
00628101633622OhioOHIO MEDICAL, LLCBYX2026-10-26
00628101633639OhioOHIO MEDICAL, LLCBYX2026-10-26
00628101633653OhioOHIO MEDICAL, LLCBYX2026-10-26
00628101633660OhioOHIO MEDICAL, LLCBYX2026-10-26
00628101633448OhioOHIO MEDICAL, LLCBYX2026-10-15
00628101633455OhioOHIO MEDICAL, LLCBYX2026-10-15
00628101633462OhioOHIO MEDICAL, LLCBYX2026-10-15
00628101633530OhioOHIO MEDICAL, LLCBYX2026-10-15
00628101633547OhioOHIO MEDICAL, LLCBYX2026-10-15
00628101633554OhioOHIO MEDICAL, LLCBYX2026-10-15
00628101633585OhioOHIO MEDICAL, LLCBYX2026-10-15
00628101633592OhioOHIO MEDICAL, LLCBYX2026-10-15
00628101633608OhioOHIO MEDICAL, LLCBYX2026-10-15
00628101633615OhioOHIO MEDICAL, LLCBYX2026-10-15
00628101633400OhioOHIO MEDICAL, LLCBYX2026-10-12
00749756403375DeRoyalDEROYAL INDUSTRIES, INC.BYX2026-09-30
00628101633356OhioOHIO MEDICAL, LLCBYX2026-09-29
00628101633417OhioOHIO MEDICAL, LLCBYX2026-09-29
00848530087142Respiratory AccessorySunset Healthcare Solutions, Inc.BYX2025-11-19
00848530070236CPAP TubingSunset Healthcare Solutions, Inc.BYX2025-05-19
00848530070281CPAP TubingSunset Healthcare Solutions, Inc.BYX2025-05-19
00789091681564Oxygen TubeSunset Healthcare Solutions, Inc.BYX2025-05-13
00789091681595CPAP TubeSunset Healthcare Solutions, Inc.BYX2025-05-13
00789091681601CPAP TubeSunset Healthcare Solutions, Inc.BYX2025-05-13
00848530089375Suction KitSunset Healthcare Solutions, Inc.BYX2025-04-15
00848530094232AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094256AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07