Orchid Safety Release Valve 1812-B300

GUDID 10869184000308

The Orchid Safety Release Valve™ or Orchid SRV™ connects via standard luer-locking connection, allowing flow during IV therapy. The Orchid SRV™ is designed to allow the device to separate into two halves when longitudinal tension exceeds the SRV tension window (between 1-4.2 lbf), automatically closing the flow path to both IV extension set and IV administration set. Following separation, a component of the Orchid SRV™ is left attached to each side of the infusion system to protect the intraluminal pathway. Upon separation, replacement of the SRV™ is necessary. Follow institutional policy to replace the SRV™, or at least every seven (7) days.

Linear Health Sciences, LLC

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• Primary Device ID: 10869184000308
• NIH Device Record Key: 283a4b98-3e73-4ef2-9b4a-7c4d917ea55d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orchid Safety Release Valve
• Version Model Number: D
• Catalog Number: 1812-B300
• Company DUNS: 085781020
• Company Name: Linear Health Sciences, LLC
• Device Count: 100
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00869184000301 [Primary]
GS1	00869184000318 [Unit of Use]
GS1	10869184000308 [Package]; Contains: 00869184000301; Package: Shipper [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212064

FDA Product Code

• QOI: Intravenous Catheter Force-Activated Separation Device.

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: 2022-09-08
• Device Publish Date: 2022-08-31