Model: 140066-01
Catalog: 140066-01
DI: 50885403530270
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
STERILE WATER IRRIGATION BOTTLE 500 ML
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
eae58f70-06f6-4d72-8351-72403f4500a1
Distribution Status:
In Commercial Distribution
DUNS Number:
001292192
Device Count:
18
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
Yes
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
10885403530272
Item #1 - Device ID Type:
Unit of Use
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
50885403530270
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 62659
Name: Wound irrigation sterile water
Definition:
A fluid consisting of sterile water (no other compounds/additives) intended to be used to irrigate and clean a wound, wound dressing, or surgical site; it may in addition be intended for non-patient-contact applications (e.g., device irrigation). It is typically provided in an appropriate container. After application, this device cannot be reused.
FDA Product Codes
FRO
Dressing, wound, drug
Premarket Submissions
Submission Number:
K083042
Supplement Number:
000
Device Sizes
Device Size - Size - @attributes - Unit:
Milliliter
Device Size - Size - @attributes - Value:
500
Device Size - Size Type:
Total Volume
Environmental Conditions
Item #1 - Storage Handling Type:
Special Storage Condition, Specify
Item #1 - Storage Handling Special Condition Text:
Keep away from sunlight
Item #2 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #2 - Storage Handling High - @attributes - Value:
60
Item #2 - Storage Handling Type:
Storage Environment Temperature
Item #3 - Storage Handling Type:
Special Storage Condition, Specify
Item #3 - Storage Handling Special Condition Text:
Keep dry