DEVICE: Miller Enema Air Tip with Non-Latex Retention Cuff (10815112021181)

Device Identifier (DI) Information

Miller Enema Air Tip with Non-Latex Retention Cuff
901201
In Commercial Distribution
901201
Bracco Diagnostics Inc.
10815112021181
GS1

12
849234661 *Terms of Use
Non latex Retention Enema Tip
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
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?
11583 Enema tip, single-use
A device intended to be connected to an enema tube to facilitate delivery of an enema solution into the rectum; it is not intended to be used during colonic irrigation. It is typically designed as a one-piece, synthetic polymer, moulded nozzle that may have a slight bulb shape at the distal end to improve retention in the rectum. This is a single-use device.
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
FGD Catheter, Retention, Barium Enema With Bag
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Catheter Gauge: 48 French
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Device Record Status

7498e7dd-c402-4e7f-8770-4948804e724a
May 26, 2025
2
May 25, 2023
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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
30815112021185 48 10815112021181 In Commercial Distribution 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: 00815112021184 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
609-514-2200
xx@xx.xx
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