FDA.reportPublic FDA data

Large Manual Percussor Cup; 89mm

Primary DI
10858409005624
Brand
Large Manual Percussor Cup; 89mm
Company
Medicomp
Model
MC-2289
Catalog number
MC-2289
Device description
Large Manual Percussor Cup; 89mm
Published
2020-04-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
GWZPercussor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWZPercussorNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10858409005624PackageGS140In Commercial Distribution
00858409005627PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085840900562410858409005624
00858409005627008584090056278584090056270858409005627

GMDN Terms#

Term, Definition table
TermDefinition
Manual chest percussorA hand-held device designed to facilitate manual percussion (rapid tapping) to provide external vibrations to the chest wall of a patient (neonate to adult) 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 is typically made of soft plastic, in the shape of a cup with a short handle, and available in a range of sizes. This a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
154454730
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
00858409005009Adult Bacterial/Viral FilterMC-500MC-5002016-09-26
00858409005269Small/Medium CPAP Cap OnlyMC-1111MC-11112017-09-11
00858409005276Large CPAP Cap OnlyMC-1212MC-12122017-09-11
00858409005436Small/Medium CPAP Cap Only MC-1111SSMC-1111SS2017-09-11
00858409005443Large CPAP Cap OnlyMC-1212SSMC-1212SS2017-09-11
00858409005016Infant Bacterial/Viral FilterMC-125MC-1252017-09-11
00858409005399Metered Dose ElbowMC-1423MC-14232017-09-11
00858409005405Metered Dose Straight SwivelMC-1523MC-15232017-09-11
00858409005023Nebulizer Bacteria FilterMC-350MC-3502017-09-11
00858409005030Spirometer Bacterial/Viral FilterMC-850MC-8502017-09-11
00858409005290Bronchoscopy Suction Swivel AdapterMC-3125MC-31252017-09-11
00858409005337Dual Swivel ElbowMC-4450MC-44502017-09-15
00858409005344Dual Swivel Elbow with Suction PortMC-4475MC-44752017-09-15
00858409005351Single Straight Swivel ConnectorMC-4490MC-44902017-09-15
00858409005368Adult Bacterial/Viral Filter with C02 PortMC-555XMC-555X2017-09-11
00858409005450"Dual Swivel Elbow, 6"" Expandable Tubing"MC-5450MC-54502017-09-15
00858409005467"Dual Swivel Elbow, 6"" Expandable Tubing with 22F Connector"MC-5460MC-54602017-09-15
00858409005474"Dual Swivel Elbow with Suction Port, 6"" Expandable Tubing"MC-5475MC-54752017-09-15
00858409005481"Dual Swivel Elbow with Suction Port, 6"" Expandable Tubing with 22F Connector"MC-5480MC-54802017-09-15
00858409005498"Single Straight Swivel Connector, 6"" Expandable Tubing"MC-5490MC-54902017-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00634782101770ADC®AMERICAN DIAGNOSTIC CORPGWZ2026-03-30
00840183526481BR Surgical, LLCBR Surgical, LLCGWZ2024-05-20
00862528000319FluidFloMED SYSTEMS INCGWZ2023-09-05
00840183501389BR Surgical, LLCBR Surgical, LLCGWZ2023-03-28
00840183505318BR Surgical, LLCBR Surgical, LLCGWZ2023-03-28
00840183506728BR Surgical, LLCBR Surgical, LLCGWZ2023-03-28
00840183507343BR Surgical, LLCBR Surgical, LLCGWZ2023-03-28
00840183508760BR Surgical, LLCBR Surgical, LLCGWZ2023-03-28
00840183519599BR Surgical, LLCBR Surgical, LLCGWZ2023-03-28
00634782099060ADC®AMERICAN DIAGNOSTIC CORPGWZ2023-01-11
00786511000257Hammer RASHMAN CORPORATIONGWZ2022-12-06
00786511075132Hammer RASHMAN CORPORATIONGWZ2022-12-06
00786511075149Hammer RASHMAN CORPORATIONGWZ2022-12-06
00786511247966Hammer RASHMAN CORPORATIONGWZ2022-12-06
00786511247973Hammer RASHMAN CORPORATIONGWZ2022-12-06
00786511620257Hammer RASHMAN CORPORATIONGWZ2022-12-06
00786511630256Hammer RASHMAN CORPORATIONGWZ2022-12-06
00786511870256Hammer RASHMAN CORPORATIONGWZ2022-12-06
00786511000240hammer RASHMAN CORPORATIONGWZ2022-12-02
00786511000264Hammer RASHMAN CORPORATIONGWZ2022-12-02
00786511000288Hammer RASHMAN CORPORATIONGWZ2022-12-02
00786511566098HammerRASHMAN CORPORATIONGWZ2022-12-02
00786511788346HammerRASHMAN CORPORATIONGWZ2022-12-02
00786511787585Prestige MedicalRASHMAN CORPORATIONGWZ2020-10-08
04046826046101MediconMedicon eG. Chirurgiemechaniker-GenossenschaftGWZ2020-09-24
04046826046118MediconMedicon eG. Chirurgiemechaniker-GenossenschaftGWZ2020-09-24
04046826046194MediconMedicon eG. Chirurgiemechaniker-GenossenschaftGWZ2020-09-24
04046826046262MediconMedicon eG. Chirurgiemechaniker-GenossenschaftGWZ2020-09-24
04046826046057MediconMedicon eG. Chirurgiemechaniker-GenossenschaftGWZ2020-09-24
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