FDA.reportPublic FDA data

Acanthus

Primary DI
00860010482674
Brand
Acanthus
Company
Acanthus Medical Creations LLC
Model
ANBP01979920D
Catalog number
ANBP01979920D
Device description
Acanthus Nasal-bridge Protector Double for CPAP Mask Case of 20
Published
2026-05-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
false
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
00860010482674PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010482674008600104826748600104826740860010482674

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.

Regulatory Flags#

DUNS number
065124205
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00860010190814AcanthusANBP01979910ANBP019799102024-12-03
00860005762668AcanthusANGTH019801ANGTH0198012023-08-04
00860005762620AcanthusACC019795ACC0197952021-03-15
00860005762637AcanthusANCH019800ANCH0198002023-06-05
00860010482643AcanthusTMNBPNBP2023-06-05
00860005762651AcanthusANBP019799ANBP0197992023-06-05
00860010482681AcanthusTMNCHNCH2023-06-05
00860010482612AcanthusTMNBPNBP2023-06-05
00860005762613AcanthusACC019795ACC0197952021-03-15

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00609271009011DARCO® Body Armor® Toe GuardDARCO INTERNATIONAL, INC.FMP2023-02-08
00609271009103DARCO® Body Armor® Toe GuardDARCO INTERNATIONAL, INC.FMP2023-02-08
00609271009110DARCO® Body Armor® Toe GuardDARCO INTERNATIONAL, INC.FMP2023-02-08
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00609271166141DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166158DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166165DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
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