FDA.report

Love Noobs

Primary DI
05061035460486
Brand
Love Noobs
Company
ROBUST VENTURES LTD
Model
PAR-OC01-001
Device description
Oral Cleaner
Published
2024-11-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
JEWTip, Rubber, Oral Hygiene

Product Code Classifications

CodeDeviceSpecialtyClass
JEWTip, Rubber, Oral HygieneDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05061035460486PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05061035460486050610354604865061035460486

GMDN Terms

TermDefinition
Oral care swabA device designed as a piece of non-treated, absorbent material on a wooden, paper, or plastic stick and intended to moisten and clean a patient's oral cavity to maintain normal mouth patency and hygiene. It is commonly used on intensive care and long-term care patients to administer moisture, mouthwash, or medications to improve the physical condition of the oral cavity and possibly help reduce the incidence of patient infection. It is typically applied to the patient by nursing staff in hospitals and institutions, or attendants in homecare settings. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
224176304
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
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
05061035460530Love NoobsRUN-MWB01-0012025-02-21
05065009839117Love NoobsYIW-TB01-0012024-06-21
05065009839940Love NoobsYIW-TB01-0022024-06-21
05065009839070Love NoobsRBST022024-05-21
05065009839100Love NoobsRBST012024-05-21
05065009839735Love NoobsRBST032024-05-21
05065009839742Love NoobsRBST042024-05-21

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