SteriCare Solutions

GUDID 00850421008839

USP Normal Saline, 500 mL Bottle

NURSE ASSIST, INC.

Non-antimicrobial wound irrigation solution, saline

• Primary Device ID: 00850421008839
• NIH Device Record Key: 7dc698cb-09e0-4452-819c-c2cfdf191d9c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SteriCare Solutions
• Version Model Number: 6280
• Company DUNS: 869434464
• Company Name: NURSE ASSIST, INC.
• Device Count: 18
• 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	00850421008839 [Unit of Use]
GS1	10850421008836 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-11-28
• Device Publish Date: 2022-09-16

On-Brand Devices [SteriCare Solutions]

• 00850421008785: 500 ML, USP STERILE WATER, BOTTLE
• 00850421008846: 6281
• 00850421008822: 6270
• 00850421008815: 6240
• 00850421008877: USP Normal Saline, 120 mL Cup
• 00850421008839: USP Normal Saline, 500 mL Bottle
• 00850421008754: USP Normal Saline, Would Flush, 3 oz
• 00850421008747: USP Normal Saline, Wound Flush, 7 oz
• B15064927750: USP Normal Saline, 100 mL Bottle
• 00850421008891: 500 ML, USP STERILE WATER, BOTTLE
• 00850421008198: USP Normal Saline, 500 mL Bottle