AccessGUDID - DEVICE: Natus® (00382830057325)

GUDID

Device Identifier (DI) Information

Brand Name: Natus®
Version or Model: NT8502001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NT8502001
Company Name: NATUS MEDICAL INCORPORATED

Primary DI Number: 00382830057325
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081325959 *Terms of Use
Previous DI: 10381780072362

Device Description: Disposable Peritoneal Catheter Passer (60 cm)

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?
46801	Subcutaneous tunneller, single-use	A hand-held manual surgical instrument designed to create a subcutaneous tunnel (artificial passageway) between percutaneous entry and exit incisions for the subcutaneous placement of a device (e.g., catheter for medication administration, shunt). It is available in a variety of forms and may be: 1) a luminal sheath with a removable inner obturator, intended for co-axial device introduction, followed by sheath removal; or 2) a non-luminal device intended to either lead or pull the device through subcutaneous tissue. It is not intended for tunnelling through deep tissues and is not a dedicated pacing or defibrillation lead tunneller. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GYK	Instrument, Shunt System Implantation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K895868	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Obturator length: 60.0 cm

Device Record Status

Public Device Record Key: 02bfbd9f-eccb-4a2b-bc5b-9db4106e01d1
Public Version Date: February 20, 2025
Public Version Number: 3
DI Record Publish Date: April 17, 2020