FDA.report

Carex Health Brands

Primary DI
30023601064012
Brand
Carex Health Brands
Company
COMPASS HEALTH BRANDS CORP.
Model
FGR40100 0000
Device description
Mini Nebulizer Compressor
Published
2016-10-07
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

Related Records

Contact Domains

Product Codes

CodeName
BTICompressor, Air, Portable

Product Code Classifications

CodeDeviceSpecialtyClass
BTICompressor, Air, PortableAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30023601064012PackageGS16In Commercial Distribution
00023601064011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
3002360106401230023601064012
00023601064011000236010640110236010640110023601064011

GMDN Terms

TermDefinition
Ambulatory nebulizer, non-heatedAn electrically-powered, hand-held, portable device intended to be used in the home to generate non-heated aerosolized medication/fluids for inhalation by a patient, typically to treat/manage a respiratory disorder [e.g., asthma, chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It may employ various technologies (ultrasonic, vibrating mesh, or compressor jet type) and consists of a pocket-size unit containing a reservoir to be filled with medication/fluids, and a retractable mouthpiece or attached mask. This device is not a nebulizing chamber.

Sterilization Methods

Method

Contacts

PhoneEmail
800-376-7263customerservice@compasshealthbrands.com

Regulatory Flags

DUNS number
827221698
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
false
Sterilization required before use
false

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