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

Luer/Luer breakaway connector
Primary Device ID10869184000308
NIH Device Record Key283a4b98-3e73-4ef2-9b4a-7c4d917ea55d
Commercial Distribution StatusIn Commercial Distribution
Brand NameOrchid Safety Release Valve
Version Model NumberD
Catalog Number1812-B300
Company DUNS085781020
Company NameLinear Health Sciences, LLC
Device Count100
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100869184000301 [Primary]
GS100869184000318 [Unit of Use]
GS110869184000308 [Package]
Contains: 00869184000301
Package: Shipper [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QOIIntravenous Catheter Force-Activated Separation Device.

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-08
Device Publish Date2022-08-31

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