Home GUDID 00860005762606 Acanthus
Primary DI 00860005762606
Brand Acanthus
Company Acanthus Medical Creations LLC
Model ACC019796
Catalog number ACC019796, ACC0197963, ACC0197969, ACC01979602
Device description Acanthus Condom Catheter Medium-Large with 3ml Skin Adhesive
Published 2021-02-15
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC true Product Codes# Code, Name table Code Name NNY Sheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-Sterile
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NNY Sheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-Sterile Gastroenterology, Urology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00860005762637 Package GS1 30 In Commercial Distribution 00860005762651 Package GS1 10 In Commercial Distribution 00860005762675 Package GS1 20 In Commercial Distribution 00860005762682 Package GS1 10 In Commercial Distribution 00860005762699 Package GS1 50 In Commercial Distribution 00860010190869 Package GS1 3 In Commercial Distribution 00860010190883 Package GS1 6 In Commercial Distribution 00860010482612 Package GS1 9 In Commercial Distribution 20860005762600 Package GS1 50 In Commercial Distribution 30860005762607 Package GS1 30 In Commercial Distribution 40860005762604 Package GS1 10 In Commercial Distribution 50860005762601 Package GS1 15 In Commercial Distribution 60860005762608 Package GS1 2 In Commercial Distribution 00860005762606 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00860005762637 00860005762637 860005762637 0860005762637 00860005762651 00860005762651 860005762651 0860005762651 00860005762675 00860005762675 860005762675 0860005762675 00860005762682 00860005762682 860005762682 0860005762682 00860005762699 00860005762699 860005762699 0860005762699 00860010190869 00860010190869 860010190869 0860010190869 00860010190883 00860010190883 860010190883 0860010190883 00860010482612 00860010482612 860010482612 0860010482612 20860005762600 20860005762600 30860005762607 30860005762607 40860005762604 40860005762604 50860005762601 50860005762601 60860005762608 60860005762608 00860005762606 00860005762606 860005762606 0860005762606
GMDN Terms# Term, Definition table Term Definition Penis wearable urinal A non-sterile, externally-worn, urine drainage device intended to be worn over the penis of an incontinent male patient to channel urine, via a tube, into a collection bag. It consists of a urinary incontinence penis attachment (e.g., sheath or adhesive port), tubing, and a wearable urine collection bag. The device is intended to provide an alternative to inserting a catheter through the urethra, especially when difficulty is encountered in insertion or retention, and eliminates the need for groin and waist straps. It may be used to treat urinary incontinence or for non-ambulatory patients. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Lumen/Inner Diameter 26.98 Millimeter
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Standard Room Temperature Conditions
Regulatory Flags# DUNS number 065124205 Device count 1 Premarket exempt true Kit true Lot or batch true Expiration date on label true No natural rubber latex true Other Devices From This Company# Other Devices Sharing Product Codes#