DEVICE: LoFric® Hydro-Kit™ (07392532148569)

Device Identifier (DI) Information

LoFric® Hydro-Kit™
42514
Not in Commercial Distribution
4251440
Wellspect AB
07392532148569
GS1
April 14, 2022
1
351118942 *Terms of Use
Single Use Urinary Catheter LoFric Hydro-Kit Coudé 16" 14FR
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
No
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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
45605 Single-administration urethral catheterization kit, single-use
A sterile collection of devices that includes a urological catheter (with or without a urine drainage bag), a cap, and other related accessories intended for one-time, self-urinary catheterization. The catheter is inserted through the urethra by the patient to provide urine drainage. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
EZD CATHETER, STRAIGHT
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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 place at room temperature.
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Clinically Relevant Size

[?]
Size Type Text
Catheter Gauge: 14 French
Length: 16 Inch
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Device Record Status

7e213ae2-1df7-4d0e-b2ac-d7039c55d833
March 30, 2023
4
November 23, 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
07392532175008 2 07392532174995 2022-04-13 Not in Commercial Distribution
07392532174995 20 07392532148569 2022-04-13 Not in Commercial Distribution
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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(877)456-3742
info-lofric-usa@wellspect.com
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