FDA.report

USV 2010

Primary DI
04260217220028
Brand
USV 2010
Company
W. Krömker GmbH
Model
2010-80-0-000-00
Device description
SU99 für WestPrime
Published
2020-02-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
CAFNebulizer (Direct Patient Interface)

Product Code Classifications

CodeDeviceSpecialtyClass
CAFNebulizer (Direct Patient Interface)Anesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
42602172200002PreviousGS10
04260217220028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
4260217220000242602172200002
04260217220028042602172200284260217220028

GMDN Terms

TermDefinition
Ultrasonic nebulizing systemAn assembly of devices designed to generate aerosolized medication/fluids (finely dispersed airborne droplets) for inhalation by a patient with a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It typically consists of a mains electricity (AC-powered) electronic oscillator, an ultrasound transducer (piezoelectric crystal), a coupling basin, a nebulizer chamber and a fan. A high frequency (e.g., 1-2 MHz) electrical current is applied to the crystal within the oscillator circuit converting it to vibrations which produce sound waves. The coupler (water or saline) transmits the sound waves to the medicated solution in the nebulizing chamber.

Sterilization Methods

Method

Contacts

PhoneEmail
(714) 529-2027javier.ortiz@westprime.com

Regulatory Flags

DUNS number
318382280
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
04260217220011USV 20102010-71-0-000-002020-02-05
42602172200002USV 20102010-80-0-000-002016-09-01
42602172200019USV 20102010-71-0-000-002016-09-01

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