FDA.reportPublic FDA data

29V11 Femcare LLC

Primary DI
00860012328758
Brand
29V11 Femcare LLC
Company
29V11 Femcare LLC
Model
Extra-long pad 320 absorbency
Device description
Natural cotton Extra-long pad 320 absorbency
Published
2025-02-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HHDPad, Menstrual, Unscented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HHDPad, Menstrual, UnscentedObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860012328758PackageGS18In Commercial Distribution
00860012328796PrimaryGS10
08432984001995Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860012328758008600123287588600123287580860012328758
00860012328796008600123287968600123287960860012328796
08432984001995084329840019958432984001995

GMDN Terms#

Term, Definition table
TermDefinition
Menstrual pad, unscentedA non-deodorized, feminine hygiene product (a pad) that is held in place externally to absorb menstrual or other vaginal discharge. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9733806091info@29v11femcare.com

Regulatory Flags#

DUNS number
136033299
Device count
8
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
0086001232871029V11 Femcare LLCcard board applicator, super plus, 12-15g absorben2025-02-13
0086001232879629V11 Femcare LLCExtra-long pad 320 absorbency 2025-02-13
0086001232878929V11 Femcare LLCcard board applicator, super plus, 12-15g absorben2025-02-13
0086001232872729V11 Femcare LLCRegular tampon cardboard applicator 6-9g absorbenc2025-02-13
0086001232876529V11 Femcare LLCUltrathin Day pads 240 absorbency2025-02-11
0086001232873429V11 Femcare LLCUltrathin Day pads 240 absorbency2025-02-11

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