FDA.reportPublic FDA data

Acanthus

Primary DI
00860010190814
Brand
Acanthus
Company
Acanthus Medical Creations LLC
Model
ANBP01979910
Catalog number
ANBP01979910
Device description
Acanthus Nasal-bridge Protector for CPAP Mask Case of 10
Published
2024-12-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
FMPProtector, Skin Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMPProtector, Skin PressureGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860010190814PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010190814008600101908148600101908140860010190814

GMDN Terms#

Term, Definition table
TermDefinition
Dressing-fixation skin adhesive tape, siliconeA long and narrow flexible band of plastic, fabric or other material, with an adhesive layer made of soft silicone, designed to cover a surface (e.g., small wound), fix a dressing, or attach objects/devices to the body. The silicone layer is intended to be less allergenic and to allow for easy removal with less trauma to skin and less adhesion to bodily hair than conventional pressure-sensitive adhesives. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
065124205
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860010482674AcanthusANBP01979920DANBP01979920D2026-05-27
00860005762606AcanthusACC019796ACC019796, ACC0197963, ACC0197969, ACC019796022021-02-15
00860010482605AcanthusTMNCHNCH2023-06-05
00860010190845AcanthusANCH01980010ANCH019800102024-12-13
00860010190852AcanthusANCH01980020ANCH019800202024-12-13
00860010190838AcanthusANCH0198005ANCH01980052023-06-05
00860010482650AcanthusANBP01979912DANBP01979912D2025-07-28
00860010482629AcanthusANBP019799DANBP019799D2025-07-06
00860010190890AcanthusANBP01979915ANBP019799152025-05-17
00860010190876AcanthusANBP01979907ANBP019799072025-04-09
00860010190821AcanthusANBP01979920ANBP019799202024-12-03
00860010190807AcanthusANBP0197995ANBP01979952023-06-05
00860005762668AcanthusANGTH019801ANGTH0198012023-08-04
00860005762620AcanthusACC019795ACC0197952021-03-15
00860005762637AcanthusANCH019800ANCH0198002023-06-05
00860010482643AcanthusTMNBPNBP2023-06-05
00860005762651AcanthusANBP019799ANBP0197992023-06-05
00860010482681AcanthusTMNCHNCH2023-06-05
00860010482612AcanthusTMNBPNBP2023-06-05
00860005762613AcanthusACC019795ACC0197952021-03-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00089904011510Action®ACTION PRODUCTS, INC.FMP2026-10-14
00089904011527Action®ACTION PRODUCTS, INC.FMP2026-10-14
00850018561037Gel-E DonutINTERNATIONAL BIOMEDICAL, LTD.FMP2026-10-13
00850018561044Gel-E DonutINTERNATIONAL BIOMEDICAL, LTD.FMP2026-10-13
00850018561051Gel-E DonutINTERNATIONAL BIOMEDICAL, LTD.FMP2026-10-13
00850018561068SquishonINTERNATIONAL BIOMEDICAL, LTD.FMP2026-10-13
00850018561075SquishonINTERNATIONAL BIOMEDICAL, LTD.FMP2026-10-13
00850018561082SquishonINTERNATIONAL BIOMEDICAL, LTD.FMP2026-10-13
00089904011503Action®ACTION PRODUCTS, INC.FMP2026-09-30
07333350181475Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-22
07333350455873Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-22
07333350647292Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-22
07333350743918Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-22
07333350775360Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-22
07333350462161Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-21
07333350529079Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-21
07333350768249Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-21
00860015694713Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00860015694720Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00860015694737Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00860015694744Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00860015694751Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00860015694768Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00089904011459Action®ACTION PRODUCTS, INC.FMP2026-07-23
00089904011435Action®ACTION PRODUCTS, INC.FMP2026-07-21
00089904011442Action®ACTION PRODUCTS, INC.FMP2026-07-21
00609271999336Aircore™ Offloading InsoleDARCO INTERNATIONAL, INC.FMP2026-07-20
00609271999343Aircore™ Offloading InsoleDARCO INTERNATIONAL, INC.FMP2026-07-20
00609271999374Aircore™ Offloading InsoleDARCO INTERNATIONAL, INC.FMP2026-07-20
00609271999381Aircore™ Offloading InsoleDARCO INTERNATIONAL, INC.FMP2026-07-20