AccessGUDID - DEVICE: BLUE CAP, NON-VENTED FEMALE (B066000325011NS1)

GUDID

Device Identifier (DI) Information

Brand Name: BLUE CAP, NON-VENTED FEMALE
Version or Model: 000325-011NS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 000325-011NS
Company Name: NOVOSCI CORP.

Primary DI Number: B066000325011NS1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 5000
Labeler D-U-N-S® Number*: 938289980 *Terms of Use

Device Description: A small, noninvasive, closed-ended Luer attachment intended to be attached to a luminal device (e.g., catheter, intravenous administration or pressure-monitoring tubing, syringe) with a Luer connection to close the device lumen, typically to prevent fluid path contamination and/or spillage; it is not intended to disinfect/maintain disinfection. It is typically made of synthetic polymers and may incorporate a strap; it does not incorporate a filter or valve. 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?
63614	Luer-formatted protective cap	A small, noninvasive, closed-ended Luer attachment intended to be attached to a luminal device (e.g., catheter, intravenous administration or pressure-monitoring tubing, syringe) with a Luer connection to close the device lumen, typically to prevent fluid path contamination and/or spillage; it is not intended to disinfect/maintain disinfection. It is typically made of synthetic polymers and may incorporate a strap; it does not incorporate a filter or valve. 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: d9b26a8f-67a2-41c0-a61a-3c28c1536b32
Public Version Date: July 13, 2023
Public Version Number: 4
DI Record Publish Date: October 13, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
B066000325011NS6	30000	B066000325011NS1	In Commercial Distribution	CASE
B066000325011NS5	25000	B066000325011NS1	In Commercial Distribution	PARTIAL CASE
B066000325011NS4	20000	B066000325011NS1	In Commercial Distribution	PARTIAL CASE
B066000325011NS3	15000	B066000325011NS1	In Commercial Distribution	PARTIAL CASE
B066000325011NS2	10000	B066000325011NS1	In Commercial Distribution	PARTIAL CASE