DEVICE: Ulti-Flo General Purpose Drainage Catheter (H862LBL21430HB0)
Device Identifier (DI) Information
Ulti-Flo General Purpose Drainage Catheter
LBL2-1430HB
In Commercial Distribution
LBL2-1430HB
URESIL, LLC
LBL2-1430HB
In Commercial Distribution
LBL2-1430HB
URESIL, LLC
HYDROPHILIC COATED LARGE BORE LOCKING CATHETER WITH DEPTH MARKS, 14F
Device Characteristics
Labeling does not contain MRI Safety Information | |
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Yes | |
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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? |
---|---|---|---|---|
34923 | Suction system catheter, general-purpose |
A sterile flexible tube used in the removal of fluids from the body via a natural body orifice, surgical incision, or wound. It is typically designed to be attached to a collection canister or bottle where a vacuum is created by a suction system via an intermediate tubing. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GBO | Catheter, Nephrostomy, General & Plastic Surgery |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Catheter Gauge: 14 French |
Length: 19 Centimeter |
Device Record Status
798b98fe-ce5b-48c0-9c9e-d84b9e820cb6
April 29, 2022
5
September 05, 2016
April 29, 2022
5
September 05, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
H862LBL21430HB2 | 4 | H862LBL21430HB1 | 2027-02-28 | In Commercial Distribution | Shipper |
H862LBL21430HB1 | 5 | H862LBL21430HB0 | 2027-02-28 | Not in Commercial Distribution | Dispenser |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-800-538-7374
sales@uresil.com
sales@uresil.com