AccessGUDID - DEVICE: 3/8" CORONARY PERFUSION PLUG (B066201022NS1)

GUDID

Device Identifier (DI) Information

Brand Name: 3/8" CORONARY PERFUSION PLUG
Version or Model: 201022NS
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 201022NS
Company Name: NOVOSCI CORP.

Primary DI Number: B066201022NS1
Issuing Agency: HIBCC
Commercial Distribution End Date: July 13, 2023
Device Count: 100
Labeler D-U-N-S® Number*: 938289980 *Terms of Use

Device Description: 3/8" TUBING TO FIT OVER THE CORONARY PERFUSION OUTLET PORT OF AN OXYGENATOR, TO SECURELY SEAL OFF THE PORT, THUS REDUCING THE POSSIBLITY OF THE PORT BEING INADVERTENTLY OPENED DUTING THE HEMOPERFUSION PROCEEDURE.

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):	No
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
DTL	Adaptor, Stopcock, Manifold, Fitting, 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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

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: 0e49c699-8f16-4cc4-9185-909f02d10841
Public Version Date: July 14, 2023
Public Version Number: 3
DI Record Publish Date: October 09, 2015