AccessGUDID - DEVICE: Nix (00363736000158)

GUDID

Device Identifier (DI) Information

Brand Name: Nix
Version or Model: 10363736000155
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Medtech Products Inc.

Primary DI Number: 00363736000158
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 060272465 *Terms of Use

Device Description: Nix Ultra Shampoo

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:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
45370	Lice removal/prevention kit	A collection of non-sterile devices intended to physically and chemically remove human head lice (Pediculus humanus capitis) and/or their eggs (nits) from an infested individual, and/or to prevent (re)infestation. It includes a lice removal and/or prevention agent(s) [e.g., shampoo, solution, emulsion] and also includes additional devices, typically one or more of the following: manual lice comb, shower cap, laundry additive. It does not include lice vacuuming devices. It is normally available [non-prescription] over-the-counter (OTC). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LIL	Monitor, Penile Tumescence

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: 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: 7287ee90-8779-4e91-a27c-593acf7d2e1f
Public Version Date: July 03, 2023
Public Version Number: 2
DI Record Publish Date: June 24, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10363736000155	1	00363736000158		In Commercial Distribution	Single

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 1-888-542-3546
Email: xx@xx.xx

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