AccessGUDID - DEVICE: NEXA NPWT DRESSING -125mmHg (35060826400015)

GUDID

Device Identifier (DI) Information

Brand Name: NEXA NPWT DRESSING -125mmHg
Version or Model: 414-00-101
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NEXA MEDICAL LIMITED

Primary DI Number: 35060826400015
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 221046947 *Terms of Use

Device Description: Nexa NPWT dressing -125mmHg pressure level. To be used in conjunction with Nexa Device and Nexa Fluid Container Pack

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?
47956	Negative-pressure wound therapy system dressing set	A collection of devices that composes a sterile dressing pack used with the pump and collection container of a negative pressure wound therapy (NPWT) system to treat hard-to-heal open wounds (e.g., acute, traumatic, and chronic) and diabetic/pressure ulcers. It typically includes dressing (e.g., open-cell foam or medicated gauze), an airtight adhesive drape, a drain, an evacuation tube, and sterile saline. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OMP	Negative Pressure Wound Therapy Powered Suction Pump

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K162610	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
No Device Sizes

Device Record Status

Public Device Record Key: dd0cee45-e3cf-47d0-a773-836462700add
Public Version Date: September 07, 2023
Public Version Number: 1
DI Record Publish Date: August 30, 2023