FDA.reportPublic FDA data

AcanthusTM

Primary DI
00860010482605
Brand
AcanthusTM
Company
Acanthus Medical Creations LLC
Model
NCH
Catalog number
NCH
Device description
Acanthus Nasal Cannula Holder (30 pairs)
Published
2023-06-05
Public version status
Update
Distribution status
Not 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
JAYSupport, Breathing Tube

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAYSupport, Breathing TubeAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860010482605PrimaryGS10
00860010482681Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010482605008600104826058600104826050860010482605
00860010482681008600104826818600104826810860010482681

GMDN Terms#

Term, Definition table
TermDefinition
Personal device holder, single-useA portable, flexible device designed to hold a portable medical device (e.g., long-term recorder, portable oxygen equipment, urine collection bag, tracheostoma protector) during ambulation or sleep; it is neither designed to hold an invasive tube/catheter to the skin surface (i.e., not a catheter/tube holder), nor to house and protect a device from damage (i.e., not a rigid case/housing). It is typically designed as a bag, pouch, belt or strap intended to pass through the personal device’s slots, or clothing. This is a single-use device.

Regulatory Flags#

DUNS number
065124205
Device count
60
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
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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