DEVICE: LoFric® Hydro-Kit™ (07392532138645)
Device Identifier (DI) Information
LoFric® Hydro-Kit™
42014
In Commercial Distribution
4201440
Dentsply Ih AB
42014
In Commercial Distribution
4201440
Dentsply Ih AB
Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 16" 14FR
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. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EZD | CATHETER, STRAIGHT |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Store in a dry place at room temperature. |
Clinically Relevant Size
[?]Size Type Text |
---|
Catheter Gauge: 14 French |
Length: 16 Inch |
Device Record Status
a8b53c1d-3ac1-449b-8196-de9eb66ec0c3
March 29, 2018
2
November 23, 2016
March 29, 2018
2
November 23, 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 |
---|---|---|---|---|---|
07392532155260 | 2 | 07392532155253 | In Commercial Distribution | Transport Packaging | |
07392532155253 | 20 | 07392532138645 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
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(877)456-3742
info-lofric-usa@wellspect.com
info-lofric-usa@wellspect.com