FDA.report

The MetaNeb® System

Primary DI
00887761997127
Brand
The MetaNeb® System
Company
HILL-ROM SERVICES PTE. LTD.
Model
173556
Published
2016-10-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
NHJDEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT

Product Code Classifications

CodeDeviceSpecialtyClass
NHJDevice, Positive Pressure Breathing, IntermittentAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00887761997127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00887761997127008877619971278877619971270887761997127

GMDN Terms

TermDefinition
Chest-oscillation airway secretion-clearing systemAn assembly of devices designed to provide high frequency chest wall oscillation (HFCWO) for external chest wall manipulation intended to loosen excessive airway secretions [mucus or sputum (phlegm)] to promote airway clearance and improve bronchial drainage for patients with respiratory disease [e.g., cystic fibrosis (CF), neuromuscular disease, bronchitis, bronchiectasis, chronic obstructive pulmonary disease (COPD)]. It consists of a mains electricity (AC-powered) oscillating pressurized air generator, an inflatable vest (jacket) to be worn by the patient and a connecting hose. It is intended to be operated by a healthcare professional in a professional setting.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)445-3730us.customerservice@hill-rom.com

Regulatory Flags

DUNS number
595156263
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00887761976849The Vest®SystemP3006000052024-12-20
00887761967243The Vest APX SystemM084632024-09-06
00887761967366The Vest APX SystemM083682024-09-06
00887761967373The Vest APX SystemM083672024-09-06
00887761973473Life2000RMS010125CP2024-02-13
00887761974739Life2000BT-80-0008A2024-05-24
00887761981690Volara SystemM08594A2023-11-28
00887761978195Life2000BT-20-00072023-01-06
00887761978201Life2000BT-20-00022023-01-06
00887761975545Maximus SystemM089782021-12-02
00887761975552Maximus SystemM089772021-12-02
00887761975569Synclara Cough SystemM087892021-12-02
00887761975576Synclara Cough SystemM087882021-12-02
00887761975583Maximus SystemPOPT1HCIE2021-12-02
00887761975590Maximus SystemPOPT1ACIE2021-12-02
00887761975606Synclara Cough SystemPSC1HCIE2021-12-02
00887761975613Synclara Cough SystemPSC1ACIE2021-12-02
00887761975385The MetaNeb®SystemM088082021-12-01
00887761977419Volara SystemPVL1HCUKIR2021-02-01
00887761977426Volara SystemPVL1ACUKIR2021-02-01

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
07321822320002ClearoBreas Medical ABNHJ2026-02-17
05060405720083ClearoBreas Medical ABNHJ2025-11-03
07321820081691ClearoBreas Medical ABNHJ2025-11-03
07321820082834ClearoBreas Medical ABNHJ2025-11-03
07321820090655ClearoBreas Medical ABNHJ2025-11-03
07321820090662ClearoBreas Medical ABNHJ2025-11-03
07321820090679ClearoBreas Medical ABNHJ2025-11-03
07321820106226Clearo Patient Circuit AmericasBreas Medical ABNHJ2025-11-03
08809517011064Comfort CoughSeoil Pacific Corp.NHJ2025-02-19
10849436000737PercussionairePERCUSSIONAIRE CORPORATIONNHJ2024-08-05
10849436000706PercussionairePERCUSSIONAIRE CORPORATIONNHJ2024-06-27
10849436000713PercussionairePERCUSSIONAIRE CORPORATIONNHJ2024-06-27
08500501360013BiWaze Cough Dual Lumen Circuit With MouthpieceAbmrc LLCNHJ2024-04-01
08500501360020 BiWaze Cough Dual Lumen Circuit With Trach AdapterAbmrc LLCNHJ2024-04-01
08500501360037BiWaze Cough Dual Lumen Circuit With Face Mask - ChildAbmrc LLCNHJ2024-04-01
08500501360044BiWaze Cough Dual Lumen Circuit With Face Mask - Adult SmallAbmrc LLCNHJ2024-04-01
08500501360051BiWaze Cough Dual Lumen Circuit With Face Mask - Adult MediumAbmrc LLCNHJ2024-04-01
08500501360068BiWaze Cough Dual Lumen Circuit With Face Mask - Adult LargeAbmrc LLCNHJ2024-04-01
00887761981690Volara SystemHILL-ROM SERVICES PTE. LTD.NHJ2023-11-28
10849436000683PercussionairePERCUSSIONAIRE CORPORATIONNHJ2023-10-31
08500501360075BiWaze Clear Dual Lumen Circuit With MouthpieceAbmrc LLCNHJ2023-07-25
08500501360082BiWaze Clear Dual Lumen Circuit With Trach AdapterAbmrc LLCNHJ2023-07-25
08500501360099BiWaze Clear Dual Lumen Circuit With Face Mask - ChildAbmrc LLCNHJ2023-07-25
08500501360105BiWaze Clear Dual Lumen Circuit With Face Mask - Adult SmallAbmrc LLCNHJ2023-07-25
08500501360112BiWaze Clear Dual Lumen Circuit With Face Mask - Adult MediumAbmrc LLCNHJ2023-07-25
08500501360129BiWaze Clear Dual Lumen Circuit With Face Mask - Adult LargeAbmrc LLCNHJ2023-07-25
00849436000679PercussionairePERCUSSIONAIRE CORPORATIONNHJ2023-06-21
B965BK367BiWaze Clear SystemAbmrc LLCNHJ2023-04-14
00887761975545Maximus SystemHILL-ROM SERVICES PTE. LTD.NHJ2021-12-02
00887761975552Maximus SystemHILL-ROM SERVICES PTE. LTD.NHJ2021-12-02