FDA.report

CVS/Pharmacy

Primary DI
40050428358687
Brand
CVS/Pharmacy
Company
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Model
NS14
Device description
A portable, hand-held, battery-powered suction device designed to enable an adult to gently suction and clear excessive mucus from the nasal passages
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does n
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
JCXApparatus, Suction, Ward Use, Portable, Ac-Powered

Product Code Classifications

CodeDeviceSpecialtyClass
JCXApparatus, Suction, Ward Use, Portable, Ac-PoweredGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
40050428358687PackageGS112In Commercial Distribution
00050428358689PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
4005042835868740050428358687
00050428358689000504283586890504283586890050428358689

GMDN Terms

TermDefinition
Nasal aspirator, electricA portable, hand-held, battery-powered suction device designed to enable an adult to gently suction and clear excessive mucus from the nasal passages of an infant or child to facilitate easier breathing. It consists of a handgrip that contains the batteries, a small electric pump that creates the suction, and typically has a silicone nozzle attached to a detachable, washable, collection cup at the distal end. It is designed for domestic use and is typically applied superficially the nasal opening (i.e., not inserted into the nasal cavity). This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
303-271-0300info@180innovations.com

Regulatory Flags

DUNS number
062312574
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
false
Sterilization required before use
false

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