AccessGUDID - DEVICE: MRVLS (07290102590018)

GUDID

Device Identifier (DI) Information

Brand Name: MRVLS
Version or Model: NA
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 572808
Company Name: Elecam Medical Agricultural Cooperative Society Ltd.

Primary DI Number: 07290102590018
Issuing Agency: GS1
Commercial Distribution End Date: May 09, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 532599255 *Terms of Use

Device Description: MRVLS 4 WAY RAD Elcam Minimal Residual Volume Luer activated swabable stopcock (MRVLS)

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35375	Stopcock	A general-purpose valve that is used to regulate the direction of a liquid or a gas flow. It is typically constructed of a durable material, e.g., plastic and/or metal, and may be used for a variety of general-purpose uses. For stopcocks used in intravenous (IV) lines for injection or removal of fluids see the appropriate GMDN code. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMG	Stopcock, I.V. Set

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K060231	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 4 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Pressure: 200 KiloPascal

Device Record Status

Public Device Record Key: ad23544e-2c78-4219-af8b-1ca28c514765
Public Version Date: November 02, 2020
Public Version Number: 6
DI Record Publish Date: September 24, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
17290102590015	45	07290102590018	2018-05-09	Not in Commercial Distribution	dispenser
27290102590012	6	17290102590015	2018-05-09	Not in Commercial Distribution	Carton box