DEVICE: Aspiration and Flush Assembly (H862AFALL0)

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Device Record History
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Device Identifier (DI) Information
Aspiration and Flush Assembly
AFA-LL
In Commercial Distribution
AFA-LL
URESIL, LLC
H862AFALL0
HIBCC
April 01, 2027
1
192559557 *Terms of Use
ASPIRATION FLUSH ADAPTER – LUER LOCK SYSTEM
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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?
60538 Luer/Luer linear connector, single-use
A small, non-powered, noninvasive tubular, two-way/linear connector with a Luer connection (either lock or slip) at both ends intended to connect two luminal devices (e.g., catheter, tubing, container) with each other. It may have a straight or elbow shape; it does not incorporate a filter, valve, clamp, tubing nor puncturing component. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
GBO Catheter, Nephrostomy, General & Plastic Surgery
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization
Yes
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
No Device Sizes
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Device Record Status
4892c196-ec7a-4859-b204-ff7641382b95
May 20, 2022
5
August 29, 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
H862AFALL2 5 H862AFALL1 2027-04-01 In Commercial Distribution Shipper
H862AFALL1 5 H862AFALL0 2027-04-01 Not in Commercial Distribution Dispenser
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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

[?]
1-800-538-7374
sales@uresil.com
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