DEVICE: Cook (00827002221819)

Device Identifier (DI) Information

Cook
G22181
In Commercial Distribution
CDSG-14-175
COOK IRELAND LTD
00827002221819
GS1

1
988559035 *Terms of Use
14Fr Colon Decompression Set
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Device Characteristics

MR Safe
No
No
Yes
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?
61910 Colonic decompression tube
A sterile, thin, flexible, hollow cylinder intended to be used to mechanically decompress the colon, typically by connection to an intermittent suction system, to treat conditions including non-toxic megacolon, pseudo-obstruction (Ogilvie syndrome) and/or colonic strictures. It includes a guidewire which is inserted per rectum using a colonoscope (not included) under fluoroscopic assistance. It is made of plastic and rubber materials and may be a straight or pigtail tube with drainage bag connectors/adaptors at the proximal end. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FEG TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION
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FDA Premarket Submission

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

Sterilization

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

[?]
Storage and Handling
Special Storage Condition, Specify: Store in a dry location, away from temperature extremes
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Clinically Relevant Size

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

10e78cff-1995-4c54-b4c7-ec05cc7d93d2
March 24, 2020
3
September 24, 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
No Package DIs found
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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
Yes
No CLOSE

Customer Contact

[?]
+1(812)330-5494
sharedservices@cookmedical.com
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