FDA.reportPublic FDA data

Momcozy

Primary DI
06975983272048
Brand
Momcozy
Company
Shenzhen Lutejiacheng Supply Chain Management Co., Ltd.
Model
MCBOC01_40PC
Device description
Baby Oral Cleaner
Published
2023-11-10
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
KXFApplicator, Absorbent Tipped, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXFApplicator, Absorbent Tipped, Non-SterileGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975983272048PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975983272048069759832720486975983272048

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
615691114
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975983272482MomcozyBF007_8pcs2024-05-21
06975983272499MomcozyBF007_16pcs2024-05-21
06975983272017MomcozyBF008_2PC2023-11-08
06975983272024MomcozyBF007_4PC2023-11-08
06975983272505MomcozyBF009_12PC2024-05-23
06975983272512MomcozyBF009_20PC2024-05-23
06975983272420MomcozyNS005_45mm2024-05-21
06975983272437MomcozyNS005_55mm2024-05-21
06975983272444MomcozyNS005_65mm2024-05-21
06975983272451MomcozyNS-001_17mm 2024-05-21
06975983272468MomcozyNS-001_20mm 2024-05-21
06975983272475MomcozyNS-001_24mm 2024-05-21
06975983272390MomcozyB01_Size 5_48pc2024-05-17
06975983272406BabycozyB01_Size 4_52pc_2bags2024-05-17
06975983272413BabycozyB01_Size 5_44pc_2bags2024-05-17
06975983273021MomcozyBN0052024-01-10
06975983273120MomcozyBN0052024-01-10
06975983272352MomcozyBY001_Pink+Green2024-04-23
06975983272369MomcozyBY001_Yellow+Blue2024-04-23
06975983272376BabycozyB04_3T-4T_68pc2024-04-23

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Primary DI, Brand, Company table
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