AccessGUDID - DEVICE: Hemovac® Wound Drainage System (00889024370128)

GUDID

Device Identifier (DI) Information

Brand Name: Hemovac® Wound Drainage System
Version or Model: 00-1500-015-10
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00-1500-015-10
Company Name: ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.

Primary DI Number: 00889024370128
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 137354267 *Terms of Use

Device Description: Universal Y-Connector

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":	Yes
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?
45389	Closed-wound drain connector	A tubular, noninvasive device designed to connect compatible components of a closed-wound drainage kit (e.g., the drain tubing to the drain bag or reservoir); it is not intended to connect components of suction systems (e.g., not used in general surgery). It will typically be shaped as a straight bore connector or a Y-piece connector. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered

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: 6336875e-3ee1-4390-b4a0-b51d06e2098c
Public Version Date: September 29, 2020
Public Version Number: 1
DI Record Publish Date: September 21, 2020