FDA.reportPublic FDA data

Roscoe Medical

Primary DI
00815067013609
Brand
Roscoe Medical
Company
Drive Devilbiss Healthcare
Model
X1PASP03
Device description
Bacteria Filter for ASP-ROSP
Published
2025-08-13
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
CAHFilter, Bacterial, Breathing-Circuit
JCXApparatus, Suction, Ward Use, Portable, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAHFilter, Bacterial, Breathing-CircuitAnesthesiology2
JCXApparatus, Suction, Ward Use, Portable, Ac-PoweredGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063448000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063448000EMG AC/DC SUCTION UNITEmg Technology Co., Ltd.2006-11-30JCX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815067013609PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815067013609008150670136098150670136090815067013609

GMDN Terms#

Term, Definition table
TermDefinition
Emergency airway clearance suction system, electricA portable assembly of devices, which includes a non-surgical invasive component, intended to aspirate unwanted materials (e.g., fluids, secretions) from the airway typically during patient transport or an emergency situation (e.g., placed on a crash cart). It includes an electrically-powered suction pump, a collection container, and patient contact devices (e.g., handpiece/tip, mask), and typically also contains tubing and microbial/hydrophobic filters. The system is not intended for surgical use.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
867673159
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
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
08697645018150ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
08697645018167ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
08697645018174ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
08697645018181ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
10197344157938MEDLINEMEDLINE INDUSTRIES, INC.CAH2025-09-12
10197344157945MEDLINEMEDLINE INDUSTRIES, INC.CAH2025-09-12
00763000915681Riptide™ Aspiration PumpMicro Therapeutics, Inc.JCX2025-08-18
10889483590591AirLife™AirLife Finland OyCAH2025-04-02
07613327562590NeptuneSTRYKER CORPORATIONJCX2022-12-16
07613327563832NeptuneSTRYKER CORPORATIONJCX2022-12-16
07613327576887NeptuneSTRYKER CORPORATIONJCX2022-12-16
07640142190882EasyOne Filter SPNDD Medizintechnik AGCAH2022-12-09
07640142190899EasyOne Filter FTNDD Medizintechnik AGCAH2022-12-09
10193489339826Medline Industries, Inc.MEDLINE INDUSTRIES, INC.CAH2022-08-04
10193489139990MedlineMEDLINE INDUSTRIES, INC.CAH2022-08-03
09420012432339Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDCAH2022-08-02
10193489085600MedlineMEDLINE INDUSTRIES, INC.CAH2022-07-12
10193489025019MedlineMEDLINE INDUSTRIES, INC.CAH2022-06-10
10193489019452HYDRO-GUARD MINI BREATHING FILTER Intersurgical IncorporatedCAH2021-10-05
10190752141834AirLife™VYAIRE MEDICAL, INC.CAH2021-04-09
10190752136434Vital Signs™Vyaire GmbHCAH2021-04-02
10190752139589Vital Signs™AirLife Finland OyCAH2021-04-02
10190752135987Vital Signs™AirLife Finland OyCAH2021-03-05
10190752135994Vital Signs™AirLife Finland OyCAH2021-03-05
10190752136632Vital Signs™AirLife Finland OyCAH2021-03-05
10190752136793Vital Signs™AirLife Finland OyCAH2021-03-05
10190752136809Vital Signs™AirLife Finland OyCAH2021-03-05
10190752138094Vital Signs™VYAIRE MEDICAL, INC.CAH2021-03-05
10190752139107Vital Signs™AirLife Finland OyCAH2021-03-05
10190752139558Vital Signs™AirLife Finland OyCAH2021-03-05