DEVICE: LoFric® Hydro-Kit™ (07392532138645)

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Device Identifier (DI) Information

LoFric® Hydro-Kit™
42014
4201440
Dentsply Ih AB
07392532138645
GS1
1
Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 16" 14FR
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
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.
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FDA Product Code

[?]
Product Code Product Code Name
EZD CATHETER, STRAIGHT
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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 Status

In Commercial Distribution
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
07392532155260 2 07392532155253 In Commercial Distribution Transport Packaging
07392532155253 20 07392532138645 In Commercial Distribution
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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)

[?]
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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