FDA.reportPublic FDA data

DeVilbiss

Primary DI
00885304002338
Brand
DeVilbiss
Company
DEVILBISS HEALTHCARE LLC
Model
7305D-D
Device description
Respiratory Suction Product Description Homecare Suction Unit, NAM
Published
2020-04-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
JCXAPPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K982304000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K982304000DEVILBISS SUCTION UNITSunrise Medical Hhg, Inc.1998-09-25JCX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885304002338PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885304002338008853040023388853040023380885304002338

GMDN Terms#

Term, Definition table
TermDefinition
Airway suction catheterA flexible tube designed to be inserted through the mouth, artificial airway, tracheostomy tube, and/or nostrils, for periodic aspiration of liquids and/or semi-solids from a patient's airway (e.g., pharynx, trachea, bronchi, nasal cavity) as part of a suction system; it is not intended to inflate the lungs. It is typically made of polymer with a smooth and rounded distal-tip, often including end and side holes and a finger-controlled valve to regulate suction. This is a single-use device.

Regulatory Flags#

DUNS number
962175894
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885304032502DeVilbiss125K-XB2020-05-27
03664390148857DeVilbissMQ5890-EU2020-05-21
00885304003816DeVilbissEX3000D-6522021-04-16
00822384002025DeVilbissDV54SE2020-04-03
00885304000280DeVilbiss9354DR2020-04-03
00885304000822DeVilbiss3655LTPL-REL2020-04-03
00885304000990DeVilbiss7310PD-PS2020-04-03
00885304001164DeVilbissDV51D-HH-S2020-04-03
00885304001508DeVilbiss3655PL-JCMH2020-04-03
00885304002598DeVilbiss535D-C-CF-RE2020-04-03
00885304002635DeVilbiss535D-E-8702020-04-03
00885304002970DeVilbissPD1000A-ML6-RE2020-04-03
00885304008798DeVilbissDV57D-HH-S-HT2020-04-03
00885304022473DeVilbiss1025KS2020-04-03
00885304007142DeVilbiss3655D-6032020-02-11
00885304007197DeVilbissPD1000D-6072020-02-11
00885304007463DeVilbissDV5C-6012020-02-11
00885304006763DeVilbissDV5C-6142020-02-10
00885304002482DeVilbiss5650D-6012020-02-07
00885304002505DeVilbiss5650D-6122020-02-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842429118689MV Flow Aspiration PumpMicrovention, Inc.JCX2026-07-15
00749756401258DeRoyalDEROYAL INDUSTRIES, INC.JCX2026-01-22
10612479280554McKessonMCKESSON MEDICAL-SURGICAL INC.JCX2025-12-03
10612479280066McKessonMCKESSON MEDICAL-SURGICAL INC.JCX2025-11-19
00763000981327Riptide Collection Canister with Intermediate TubingMicro Therapeutics, Inc.JCX2025-10-31
00763000915681Riptide™ Aspiration PumpMicro Therapeutics, Inc.JCX2025-08-18
00815067013609Roscoe MedicalDrive Devilbiss HealthcareJCX2025-08-13
04719876940186ZOOM™ Duoport CanisterTaiwan Biomaterial Company LimitedJCX2025-02-24
00092237626672Roscoe MedicalDrive Devilbiss HealthcareJCX2025-02-10
00092237626627Roscoe MedicalDrive Devilbiss HealthcareJCX2025-01-29
37613327644068NeptuneSTRYKER CORPORATIONJCX2024-12-06
07613327644067NeptuneSTRYKER CORPORATIONJCX2024-12-06
00092237626689Roscoe MedicalDrive Devilbiss HealthcareJCX2024-11-19
00885304032557DeVilbissDEVILBISS HEALTHCARE LLCJCX2024-11-08
00885304032571DeVilbissDEVILBISS HEALTHCARE LLCJCX2024-11-08
37613327566162NeptuneSTRYKER CORPORATIONJCX2024-10-15
00848530091293Power and AccessoriesSUNSET HEALTHCARE SOLUTIONS, INC.JCX2024-08-08
00848530091873Power and AccessoriesSUNSET HEALTHCARE SOLUTIONS, INC.JCX2024-08-08
10848530091290Power and AccessoriesSUNSET HEALTHCARE SOLUTIONS, INC.JCX2024-08-08
00848530091378Portable SuctionSUNSET HEALTHCARE SOLUTIONS, INC.JCX2024-08-08
10848530091870Power and AccessoriesSUNSET HEALTHCARE SOLUTIONS, INC.JCX2024-08-08
00848530096199Portable SuctionSUNSET HEALTHCARE SOLUTIONS, INC.JCX2024-08-08
00848530096205Closed SuctionSUNSET HEALTHCARE SOLUTIONS, INC.JCX2024-08-08
07613327634914NeptuneSTRYKER CORPORATIONJCX2024-04-16
00848530102579Sunset Portable Suction Machine with AC/DC Power SUNSET HEALTHCARE SOLUTIONS, INC.JCX2024-03-05
10848530102576Sunset Portable Suction Machine with AC/DC Power SUNSET HEALTHCARE SOLUTIONS, INC.JCX2024-03-05
04719876940124TRUVIC GeneratorTaiwan Biomaterial Company LimitedJCX2024-02-19
00840117326576Respo-O2 Homecare Suction Unit, Portable, Batter OperatedDynarex CorporationJCX2023-12-29
00050428550014CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDJCX2023-03-09
40050428550012CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDJCX2023-03-09