FDA.reportPublic FDA data

ROSCOE

Primary DI
00092237605356
Brand
ROSCOE
Company
Drive Devilbiss Healthcare
Model
EASY-FLEX6
Device description
EASY-FLEX 6' CPAP TUBING WITH 22MM CUFFS, 19MM TUBE DIAMETER
Published
2022-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZOSet, Tubing And Support, Ventilator (W Harness)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZOSet, Tubing And Support, Ventilator (W Harness)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00092237605356PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00092237605356000922376053560922376053560092237605356

GMDN Terms#

Term, Definition table
TermDefinition
Oxygen administration tubingA length of flexible noninvasive tube, typically a small bore, thick-walled, anti-kink tubing (to prevent blockage) intended for the delivery of a pure oxygen (O2), or an O2 enriched gas, to a mask or nasal cannula (not included), during delivery of dry O2 to the patient. The tubing is typically available in standard coil lengths and is cut by clinical staff to appropriate lengths to create an extension or connecting piece. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-376-7263customerservice@compasshealthbrands.com

Regulatory Flags#

DUNS number
867673159
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10092237600105Roscoe MedicalEP4070WCD2016-10-18
90002360125501AccuReliefACRL-55002016-10-12
00009223761699Reliable MedicalEF2020BC2-TU2018-06-13
00009223761941EswallowESW-90502016-12-31
00023601005144CAREX HEALTH BRANDSFGA51400 00002022-12-20
00023601005151CAREX HEALTH BRANDSFGA51500 BLUE2022-12-20
00023601005168CAREX HEALTH BRANDSFGA51600 GRN2022-12-20
00023601005175CAREX HEALTH BRANDSFGA51700 BRNZ2022-12-20
00023601005182CAREX HEALTH BRANDSFGA51800 GRAY2022-12-20
00023601007117CAREX HEALTH BRANDSFGA71100 00002023-03-15
00023601007179CAREX HEALTH BRANDSFGA71700 00002023-03-15
00023601007186CAREX HEALTH BRANDSFGA71800 00002023-03-15
00023601007193CAREX HEALTH BRANDSFGA71900 00002023-03-15
00023601012210Carex Health BrandsFGA22100 00002022-12-09
00023601012227CAREX HEALTH BRANDSFGA22200 00002022-12-12
00023601012234CAREX HEALTH BRANDSFGA22300 00002022-12-12
00023601012302CAREX HEALTH BRANDSFGA23000 00002022-12-12
00023601012319CAREX HEALTH BRANDSFGA23177 00002022-12-12
00023601012333CAREX HEALTH BRANDSFGA23300 00002022-12-12
00023601013330CAREX HEALTH BRANDSFGA33300 00002022-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09420012402691Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-03-26
09420012433756Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-03-26
10197344011346HUDSON RCIMEDLINE INDUSTRIES, INC.BZO2026-03-13
10197344011353HUDSON RCIMEDLINE INDUSTRIES, INC.BZO2026-03-13
10197344011377HUDSON RCIMEDLINE INDUSTRIES, INC.BZO2026-03-13
09420012479105F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-01-23
09420012479129F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-01-23
09420012479143F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-01-23
09420012479167F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-01-23
10889483225653AirLife™SUNMED, LLCBZO2025-12-19
09420012414885AdaptorFISHER & PAYKEL HEALTHCARE LIMITEDBZO2025-10-07
14026704929099GIBECKTELEFLEX INCORPORATEDBZO2025-07-30
14026704660978HUDSON RCITELEFLEX INCORPORATEDBZO2025-07-07
10889483570555AirLife™AIRLIFEBZO2025-03-27
10889483571675AirLife™AIRLIFEBZO2025-03-27
10889483571682AirLife™AIRLIFEBZO2025-03-27
10889483571699AirLife™AIRLIFEBZO2025-03-27
10889483572160AirLife™AIRLIFEBZO2025-03-27
10889483588246AirLife™AIRLIFEBZO2025-03-27
10889483570227AirLife™AIRLIFEBZO2025-03-18
10889483570289AirLife™AIRLIFEBZO2025-03-18
10889483570326AirLife™AIRLIFEBZO2025-03-18
10889483570517AirLife™AIRLIFEBZO2025-03-06
10889483571705AirLife™AIRLIFEBZO2025-03-05
10889483570548AirLife™AIRLIFEBZO2025-02-26
10889483570708AirLife™AIRLIFEBZO2025-02-26
10889483570173AirLife™AIRLIFEBZO2025-02-25
10889483570197AirLife™AIRLIFEBZO2025-02-25
10889483570203AirLife™AIRLIFEBZO2025-02-25
10889483570210AirLife™AIRLIFEBZO2025-02-25