FDA UDI In Commercial Distribution 🇺🇸 United States

SENSIMEDICAL Sterile 0.9% Normal Saline, USP

DI: 00810083351247 · Model: 7871800068 · Sensimedical LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
SENSIMEDICAL Sterile 0.9% Normal Saline, USP
Primary DI
00810083351247
Version / Model
7871800068
Catalog Number
7871800068
Company Name
Sensimedical LLC
Labeler DUNS
117526048
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-10-09
Public Version
1
Public Version Date
2025-10-17
Public Version Status
New
Public Device Record Key
3cdf5663-1c30-4d0e-aa19-e7a0639c17d3

Device Description

Sterile 0.9% Normal Saline for Irrigation, USP, 1000mL Bottle (OTC)

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
FRO Dressing, Wound, Drug

GMDN Terms

Code Name
64871 Non-antimicrobial wound irrigation solution, saline

Identifiers

Type ID
Package 00810083351230
Primary 00810083351247