Device
0.9% SODIUM CHLORIDE IRRIGATION BOTTLE 1000 ML
Manufacturer
BECTON, DICKINSON AND COMPANY
BECTON, DICKINSON AND COMPANY
Model: 140067-01
Catalog: 140067-01
DI: 50885403530287
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
0.9% SODIUM CHLORIDE IRRIGATION BOTTLE 1000 ML
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
1f53326e-2c04-46da-bed7-e0f1268b26ba
Distribution Status:
In Commercial Distribution
DUNS Number:
001292192
Device Count:
9
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:
10885403530289
Item #1 - Device ID Type:
Unit of Use
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
50885403530287
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 64871
Name: Non-antimicrobial wound irrigation solution, saline
Definition:
A solution of sodium chloride (NaCl), without additional compounds (i.e., not a multiple solute solution), 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 not intended to provide antimicrobial activity and may be supplied in a plastic container with a spray nozzle; it is intended to be used in the home or healthcare facility. 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:
1000
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 dry
Item #2 - Storage Handling Type:
Special Storage Condition, Specify
Item #2 - Storage Handling Special Condition Text:
Keep away from sunlight
Item #3 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #3 - Storage Handling High - @attributes - Value:
60
Item #3 - Storage Handling Type:
Storage Environment Temperature