DEVICE: LoFric® Hydro-Kit™ (07392532148514)
Device Identifier (DI) Information
LoFric® Hydro-Kit™
42008
Not in Commercial Distribution
4200840
Wellspect AB
42008
Not in Commercial Distribution
4200840
Wellspect AB
Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 16" 08FR
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. 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 |
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: 8 French |
Length: 16 Inch |
Device Record Status
51a757e7-d22e-42e3-8259-5a2790c93fbb
March 30, 2023
4
November 23, 2016
March 30, 2023
4
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 |
---|---|---|---|---|---|
07392532155178 | 2 | 07392532155161 | 2022-04-10 | Not in Commercial Distribution | |
07392532155161 | 20 | 07392532148514 | 2022-04-10 | Not 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