FDA.reportPublic FDA data

b.pure

Primary DI
00049696889841
Brand
b.pure
Company
FOURSTAR GROUP INC.
Model
64431638
Device description
BPURE INFUSED EVERYDY LNRS 18C
Published
2023-02-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
HHLPad, Menstrual, Scented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HHLPad, Menstrual, Scented, Scented-DeodorizedObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00049696889841PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00049696889841000496968898410496968898410049696889841

GMDN Terms#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
656091279
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00049696189583THERA Plus644101842026-06-09
00049696198189B.PURE644103382026-06-09
00049696295260THERA Plus644103662026-06-09
00049696295277THERA Plus644103662026-06-09
00049696295284THERA Plus644103662026-06-09
00049696295291THERA Plus644103662026-06-09
00049696295307THERA Plus644103662026-06-09
00049696295314THERA Plus644103662026-06-09
00049696508339THERA Plus64409658V2026-06-09
00049696508346B.PURE64409346B2026-06-09
00049696508360THERA Plus64409535A2026-06-09
00049696508377THERA Plus64409535B2026-06-09
00049696508384THERA Plus64409535C2026-06-09
00049696561228THERA Plus644103222026-06-09
00049696561518B.PURE644103252026-06-09
00049696562102B.PURE644103262026-06-09
00049696677547THERA Plus644103832026-06-09
00049696712194B.PURE644102892026-06-09
00049696898232B.PURE64410005D2026-06-09
00050428284537CVSHealth64408659Y2026-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00049696889810b.pureFOURSTAR GROUP INC.HHL2023-02-05
00049696889827b.pureFOURSTAR GROUP INC.HHL2023-02-05
00049696889834b.pureFOURSTAR GROUP INC.HHL2023-02-05
04000576042103CosmeaW. Pelz GmbH & Co. KGHHL2020-09-14
04000576042110CosmeaW. Pelz GmbH & Co. KGHHL2020-09-14
04000576042141CosmeaW. Pelz GmbH & Co. KGHHL2020-09-14
04000576022969CosmeaW. Pelz GmbH & Co. KGHHL2020-09-14
04000576022983CosmeaW. Pelz GmbH & Co. KGHHL2020-09-14
04000576032500CosmeaW. Pelz GmbH & Co. KGHHL2020-09-14