FDA.reportPublic FDA data

B.PURE

Primary DI
00049696712194
Brand
B.PURE
Company
FOURSTAR GROUP INC.
Model
64410289
Device description
BP FLOWER TEETHER RATTLE TOY
Published
2026-06-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
MEFRing, Teething, Non-Fluid Filled

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MEFRing, Teething, Non-Fluid FilledDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00049696712194PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00049696712194000496967121940496967121940049696712194

GMDN Terms#

Term, Definition table
TermDefinition
Helicopter ambulanceA helicopter designed (modified and equipped) for use by emergency medical services (EMS) to transport the sick or wounded, especially as a rapid alternative to ground transport around urban areas or during military operations. It will carry onboard equipment for emergency treatment and to maintain or improve the clinical status of the patient, such as devices for carrying or supporting a patient (e.g., stretchers, splints), oxygen therapy (e.g., oxygen cylinders and tubing), intubation/chest decompression (tubes), bleeding control (e.g., bandages, tourniquets), cardioversion/defibrillation (defibrillators), and patient monitoring. It may also carry tools to help extricate a trapped patient.

Regulatory Flags#

DUNS number
656091279
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 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
00049696898232B.PURE64410005D2026-06-09
00050428284537CVSHealth64408659Y2026-06-09
00050428299838CVSHealth64408678AB2026-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00049696198189B.PUREFOURSTAR GROUP INC.MEF2026-06-09
00049696898232B.PUREFOURSTAR GROUP INC.MEF2026-06-09
00072239329252Dr. Brown'sDr. Brown's CompanyMEF2026-06-08
00072239329269Dr. Brown'sDr. Brown's CompanyMEF2026-06-08
00072239330753Dr. Brown'sDr. Brown's CompanyMEF2026-06-08
00072239331842Dr. Brown'sDr. Brown's CompanyMEF2026-06-08
00072239331859Dr. Brown'sDr. Brown's CompanyMEF2026-06-08
00072239331866Dr. Brown'sDr. Brown's CompanyMEF2026-06-08
00072239331873Dr. Brown'sDr. Brown's CompanyMEF2026-06-08
00072239331897Dr. Brown'sDr. Brown's CompanyMEF2026-06-08
00072239332139Dr. Brown'sDr. Brown's CompanyMEF2026-06-08
00072239332146Dr. Brown'sDr. Brown's CompanyMEF2026-06-08
00072239333143Dr. Brown'sDr. Brown's CompanyMEF2026-06-08
00072239333402Dr. Brown'sDr. Brown's CompanyMEF2026-06-08
00072239333457Dr. Brown'sDr. Brown's CompanyMEF2026-06-08
00072239334751Dr. Brown'sDr. Brown's CompanyMEF2026-06-08
00072239334850Dr. Brown'sDr. Brown's CompanyMEF2026-06-08
00072239334867Dr. Brown'sDr. Brown's CompanyMEF2026-06-08
00072239334874Dr. Brown'sDr. Brown's CompanyMEF2026-06-08
00072239335000Dr. Brown'sDr. Brown's CompanyMEF2026-06-08
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00850036595052Chewy TubesCASCO BAY MOLDING LTD.MEF2025-01-24
00850036595069Chewy TubesCASCO BAY MOLDING LTD.MEF2025-01-24
00850036595106Chewy TubesCASCO BAY MOLDING LTD.MEF2025-01-24