AccessGUDID - DEVICE: STOPCOCK, TMP 4-WAY W/LUER LOCK (B0662010120000)

GUDID

Device Identifier (DI) Information

Brand Name: STOPCOCK, TMP 4-WAY W/LUER LOCK
Version or Model: 201012-000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 201012-000
Company Name: NOVOSCI CORP.

Primary DI Number: B0662010120000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 938289980 *Terms of Use

Device Description: 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.

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":	No
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
DTZ	Oxygenator, Cardiopulmonary Bypass

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 86fe4aaa-0d04-4715-8d0a-67bf0e347ac2
Public Version Date: June 20, 2023
Public Version Number: 3
DI Record Publish Date: September 14, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
B0662010120007	75	B0662010120000	In Commercial Distribution	PARTIAL CASE
B0662010120006	50	B0662010120000	In Commercial Distribution	PARTIAL CASE
B0662010120005	100	B0662010120000	In Commercial Distribution	CASE
B0662010120003	25	B0662010120000	In Commercial Distribution	INNER CARTON