DEVICE: Peristeen (05708932648882)

Device Identifier (DI) Information

Peristeen
29123
In Commercial Distribution
29123
Coloplast A/S
05708932648882
GS1

1
305524696 *Terms of Use
Peristeen Anal irrigation. Accessory unit. Non sterile. Rx only.
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Device Characteristics

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

GMDN

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

GMDN Preferred Term Name GMDN Definition
Rectal irrigation system catheter A flexible tube that is a component of a rectal irrigation system and designed to be inserted into the rectum (may be held in position by an inflatable retention balloon) where it serves as a conduit for water introduced into the rectum. The irrigation is typically used to provoke the defecation reflex for the evacuation of the bowels to treat/prevent constipation and reduce the risk of faecal incontinence. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
KNT TUBES, GASTROINTESTINAL (AND ACCESSORIES)
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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

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

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Size Type Text
No Device Sizes
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Device Record Status

9a8cc02a-7f76-438b-a5f0-f2daa5712f47
March 29, 2018
2
September 20, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
05708932487009 10 05708932648882 In Commercial Distribution Retail box
05708932487016 10 05708932487009 In Commercial Distribution Shipper box
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Secondary DI

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

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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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