AccessGUDID - DEVICE: PEDIATRIC TUBING ORGANIZER

GUDID

Device Identifier (DI) Information

Brand Name: PEDIATRIC TUBING ORGANIZER - STERILE
Version or Model: 311034-000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 311034-000
Company Name: NOVOSCI CORP.

Primary DI Number: B0663110340000
Issuing Agency: HIBCC
Commercial Distribution End Date: June 20, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 938289980 *Terms of Use

Device Description: A small, sterile device with a locking/holding mechanism designed to secure most any kind of tubing or tubing-like device (e.g., cables, cords) to a patient or to a surgical drape during a clinical intervention. It is typically designed as: 1) an adhesive pad (plaster), strip, or bandage intended to attach to the patient's skin or drape with the exposed side (top side) having an integrated fixation mechanism (e.g., Velcro hook/loop closure); or 2) a mechanical closure or gripping system intended to hold the tubing or tubing hub in place. This device is not designed to hold a specific type or brand of tubing. 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):	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?
62137	Medical/surgical interventional tube/cable securement clip, single-use	A device intended to hold, position, and organize medical/surgical interventional tubing (e.g., arterial/venous lines, gas lines, drainage catheters, irrigation tubing) or cables to an equipment, drape or gown; it is not intended to affix the tubing to the patient directly. It is typically designed as a clip or a block with clips. 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: 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: bbe268b8-67c9-4ed9-a950-c1f8fd68fa87
Public Version Date: June 19, 2024
Public Version Number: 4
DI Record Publish Date: October 12, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
B0663110340007	30	B0663110340000	2023-06-20	Not in Commercial Distribution	PARTIAL CASE
B0663110340006	20	B0663110340000	2023-06-20	Not in Commercial Distribution	PARTIAL CASE
B0663110340005	40	B0663110340000	2023-06-20	Not in Commercial Distribution	CASE
B0663110340003	10	B0663110340000	2023-06-20	Not in Commercial Distribution	INNER CARTON