AccessGUDID - DEVICE: Avaline Medical NJ LLC (00653078997583)

GUDID

Device Identifier (DI) Information

Brand Name: Avaline Medical NJ LLC
Version or Model: vkssc05.2
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: vkssc05.2
Company Name: Avaline Medical NJ Limited Liability Company

Primary DI Number: 00653078997583
Issuing Agency: GS1
Commercial Distribution End Date: March 16, 2022
Device Count: 5
Labeler D-U-N-S® Number*: 079767953 *Terms of Use

Device Description: 5 Pack of Vakly 4oz Sterile Specimen Cups Individually Bagged with Screw On Lids

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?
58177	Urine specimen collection kit IVD	A collection of noninvasive devices intended to be used for the collection, preservation, and transport of a urine specimen for culture, analysis, and/or other investigation. It typically consists of a primary urine collection receptacle (e.g., cup, conical tube, vessel), a urine preservation/transport tube [typically evacuated, with or without additives], and a transfer device for facilitating the aseptic transfer of a urine sample between receptacles; supportive devices for urine collection (e.g., wet wipes, absorbent pads, Foley catheter connector) and/or analysis [e.g., microscope slides, tube rack] may also be included in the kit. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMH	CONTAINER, SPECIMEN, STERILE

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: e25c3f0e-fd11-443e-877c-29e85d740a52
Public Version Date: March 17, 2022
Public Version Number: 2
DI Record Publish Date: December 03, 2021