DEVICE: Assura (05708932020220)

Download: XML | JSON

Device Identifier (DI) Information

Assura
12835
12835
Coloplast A/S
05708932020220
GS1
1
Assura Irrigation Sleeves, 2-piece
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Colostomy irrigation sleeve A non-sterile, soft plastic, open-ended cylinder intended for use during colostomy irrigation to funnel the resultant washout fluid into a sanitary collection receptacle (e.g., a toilet). It is typically attached to a plastic flange placed around the colostomy stoma and held in place by a waist belt. This is a single-use device.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
EXD Irrigator, ostomy
CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Keep away from sunlight
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Lumen/Inner Diameter: 50 Millimeter
Lumen/Inner Diameter: 2 Inch
CLOSE

Device Status

In Commercial Distribution
September 14, 2016

CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
00762123021378 5 05708932020220 In Commercial Distribution Retail box
00762123021385 20 00762123021378 In Commercial Distribution Shipper box
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)533-0464
healthcarecs@coloplast.com
CLOSE