Areza Medical

Primary DI
00810147400225
Brand
Areza Medical
Company
ADVANCED MEDICAL ASSOCIATES, LLC
Model
COPOVV10
Catalog number
COPOVV10
Published
2024-10-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FONBag, Drainage, With Adhesive, Ostomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FONBag, Drainage, With Adhesive, OstomyGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810147400232PackageGS110In Commercial Distribution
00810147400249PackageGS130In Commercial Distribution
00810147400225PrimaryGS10
00810147400218Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810147400232008101474002328101474002320810147400232
00810147400249008101474002498101474002490810147400249
00810147400225008101474002258101474002250810147400225
00810147400218008101474002188101474002180810147400218

GMDN Terms#

Term, Definition table
TermDefinition
Intestinal ostomy bag/support kitA collection of devices intended to be used for attachment/replacement of an intestinal ostomy bag (for collecting intestinal output such as faeces following a colostomy or ileostomy procedure). It includes not only the intestinal ostomy bag and a base plate, but also additional ostomy fitting/maintenance supportive devices (e.g., towels, wipes, scissors). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool, dry place. Avoid excessive heat

Contacts#

Phone, Email table
PhoneEmail
(214) 356-8716info@arezamedical.com

Regulatory Flags#

DUNS number
047724226
Device count
10
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
00850021481766Areza MedicalRT4X11RT4X112024-11-07
00810147400263Areza MedicalCOPOV10COPOV102024-10-26
00810147400546Areza MedicalCMC42520CMC425202024-10-26
00850021481001Areza MedicalSSF91010 SSF91010 2024-10-26
00850021481674Areza MedicalBG8430 BG84302024-10-26
00850021481728Areza MedicalBG8630BG86302024-10-26
00850021481742Areza MedicalAGF42510AGF425102024-10-26
00850021481759Areza MedicalAGF42520AGF425202024-10-26
00850021481773Areza MedicalSA42520SA425202024-10-25
00850021481810Areza MedicalSA425100SA4251002024-10-25
00850021481902Areza MedicalF5410F54102024-10-26
00810147400232Areza MedicalCOPOVV10COPOVV102024-10-26
00810147400270Areza MedicalCOPOV10COPOV102024-10-26
00850021481957Areza MedicalSSF91010 SSF91010 2024-10-26
00810147400836Areza MedicalBG8430 BG84302024-10-26
00810147400850Areza MedicalBG8630BG86302024-10-26
00850021481865Areza MedicalAGF42510AGF425102024-10-26
00850021481827Areza MedicalAGF42520AGF425202024-10-26
00850021481841Areza MedicalSA42520SA425202024-10-25
00850021481872Areza MedicalSA425100SA4251002024-10-25

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