Device
Wound irrigation kit containing 14” Extremity Fluid Collection Bag, with separately packed chlorhexidine prep wipes, solidifier, and twist tie.
Manufacturer
Stiehl Tech, LLC
Stiehl Tech, LLC
Model: Extremity 14”
Catalog: WIKE1401
DI: B674WIKE1401101
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-13
Current Version: 2026-05-21
Description
Wound irrigation kit containing 14” Extremity Fluid Collection Bag, with separately packed chlorhexidine prep wipes, solidifier, and twist tie.
Sterilization
Method Types - Sterilization Method:
Radiation Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
Yes
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
3f7f8418-47a9-4ee8-acb0-397265c74948
Distribution Status:
In Commercial Distribution
DUNS Number:
081177942
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
Yes
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
B674WIKE1401101
Type:
Primary
Issuing Agency:
HIBCC
GMDN
Code: 14462
Name: Wound irrigation kit
Definition:
A collection of noninvasive devices intended to be used by a healthcare professional to irrigate/cleanse an acute, chronic, or surgical wound. It consists of multiple items which typically include an irrigation instrument (e.g., syringe, bulb), wipes, towel, drape and/or irrigation solution. This is a single-use device.
FDA Product Codes
FON
Bag, Drainage, With Adhesive, Ostomy
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling Low - @attributes - Value:
-20
Storage Handling - Storage Handling High - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling High - @attributes - Value:
60
Storage Handling - Storage Handling Type:
Storage Environment Temperature