Orchid Safety Release Valve

Primary DI
10869184000308
Brand
Orchid Safety Release Valve
Company
Linear Health Sciences, LLC
Model
D
Catalog number
1812-B300
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.
Published
2022-08-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
QOIIntravenous Catheter Force-Activated Separation Device.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QOIIntravenous Catheter Force-Activated Separation Device.General Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212064000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212064000Orchid Safety Release Valve(TM)Linear Health Sciences, LLC2022-05-03QOI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10869184000308PackageGS14In Commercial Distribution
00869184000301PrimaryGS10
00869184000318Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086918400030810869184000308
00869184000301008691840003018691840003010869184000301
00869184000318008691840003188691840003180869184000318

GMDN Terms#

Term, Definition table
TermDefinition
Luer/Luer breakaway connectorA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
085781020
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00869184000301Orchid Safety Release ValveD1812-B3002022-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00869184000301Orchid Safety Release ValveLinear Health Sciences, LLCQOI2022-08-31
10860635000311SafeBreak - VascularLineus MedicalQOI2022-06-20