DEVICE: Macy Catheter Tray (00861003000226)

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Device Identifier (DI) Information

Macy Catheter Tray
B
MCT-1001
HOSPI CORPORATION
00861003000226
GS1
1
Convenience tray for the Macy Catheter. Contents include: Macy Catheter, 60ml Enteral/Oral Syringe, 10ml Enteral/Oral Syringe, 3ml Enteral/Oral Syringe, (2) 10ml Pre-filled Balloon Inflation Syringes, Macy Catheter Instructions for Use, 3-Ply Poly Towel, Nitrile Gloves, Lubricating Jelly, Catheter Securing Device.
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Gastrointestinal dilation balloon catheter A long, thin, flexible tube with an inflatable balloon at its distal tip typically used to endoscopically dilate gastrointestinal strictures, especially of the oesophagus, pylorus, and colon. The balloon is inflated to its prescribed diameter (typically between 6 mm and 20 mm) to widen the affected passage of the tract. The device may consist of one or more lumen, and may be of the fixed-wire or wire-guided type. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
KDD Kit, Surgical Instrument, Disposable
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Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
May 13, 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
10861003000223 10 00861003000226 In Commercial Distribution 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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
888-509-3732
vivian.gordon@hospicorp.com
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