Stericare

GUDID 00850421008990

USP Normal Saline (0.9% Sodium Chloride), 1000 mL Bottle, Square Tamper Evid HWC Ster

NURSE ASSIST, INC.

Non-antimicrobial wound irrigation solution, saline

• Primary Device ID: 00850421008990
• NIH Device Record Key: bfb83576-5402-4a47-964c-6d12498434c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stericare
• Version Model Number: 6480
• Company DUNS: 869434464
• Company Name: NURSE ASSIST, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850421008990 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083042

FDA Product Code

• FRO: Dressing, Wound, Drug

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-20
• Device Publish Date: 2026-03-12

On-Brand Devices [Stericare]

• 10860013668508: USP Normal Saline (0.9% Sodium Chloride), 1000 mL Bottle, Case of 9 units, Square Tamper Evid HW
• 03085042100878: USP Sterile Water, 500 mL Bottle, Case of 18 units, Square Tamper Evid HWC Ster
• 00860013668501: USP Sterile Water, 1000 mL Bottle, Each, Square Tamper Evid HWC Ster
• 00850421008990: USP Normal Saline (0.9% Sodium Chloride), 1000 mL Bottle, Square Tamper Evid HWC Ster
• 00850421008983: USP Normal Saline (0.9% Sodium Chloride), 500 mL Bottle, Each, Square Tamper Evid HWC Ster
• 00850421008976: USP Sterile Water, 500 mL Bottle, Each, Square Tamper Evid HWC Ster