Orchid Safety Release Valve

Basic Information

• Brand Name: Orchid Safety Release Valve
• Primary DI: 00869184000301
• Version / Model: D
• Catalog Number: 1812-B300
• Company Name: Linear Health Sciences, LLC
• Labeler DUNS: 085781020
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2022-08-31
• Public Version: 2
• Public Version Date: 2023-08-07
• Public Version Status: Update
• Public Device Record Key: 283a4b98-3e73-4ef2-9b4a-7c4d917ea55d

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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	Medical Specialty	Regulation #	Device Class
QOI	Intravenous Catheter Force-Activated Separation Device.	General Hospital	880.5220	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66263	Luer/Luer breakaway connector	A small, non-powered, noninvasive, linear Luer connector intended to connect an intravenous (IV) line to a peripheral catheter/cannula during IV administration, and to facilitate safe disconnection if excessive tension is placed on the IV line (e.g., unintentional tugging or pulling). The safe disconnection feature, which is sometimes referred to as a force activated separation mechanism and designed to reduce patient injury, includes valves to prevent blood loss, contamination, and IV fluid leakage. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10869184000308	GS1	Shipper	4	In Commercial Distribution
Primary	00869184000301	GS1
Unit of Use	00869184000318	GS1