DEVICE: Assura (05708932020206)

Device Identifier (DI) Information

Assura
12820
In Commercial Distribution
12820
Coloplast A/S
05708932020206
GS1

1
305524696 *Terms of Use
Assura Irrigation, Face plate
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Device Characteristics

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

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
60968 Ostomy appliance ring/belt
A device consisting of a ring/plate and an adjustable and/or elastic belt intended to secure an ostomy appliance [e.g., bag, irrigation sleeve] (not included) to a patient’s stoma (e.g., in the intestine/colon) during use. The appliance is attached to the ring, which is attached to the belt worn by the patient. The device is typically made of synthetic polymer materials and is intended for use in the home and healthcare facility. This is a single-patient, reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
EXD Irrigator, ostomy
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Keep away from sunlight
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

e12bdaad-7b9a-4d30-b3a0-ee1731a8fa48
May 23, 2019
3
September 14, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
05708932645836 5 05708932020206 In Commercial Distribution Retail box
05708932645843 10 05708932645836 In Commercial Distribution Shipper box
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

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