AccessGUDID - DEVICE: ASP MEDICAL (00840216127753)

GUDID

Device Identifier (DI) Information

Brand Name: ASP MEDICAL
Version or Model: MRT800
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Asp Global, LLC

Primary DI Number: 00840216127753
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080361159 *Terms of Use

Device Description: SPECIMEN PAN, DELUXE, WHITE, 40 OZ, DIAGONAL PLACEMENT GRADUATIONS, LATEX FREE, 100EA/CS

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):	Yes
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?
66875	Urine specimen collection/transfer container IVD	A non-covered receptacle intended to be used for the collection of a urine specimen at the point-of-care or optionally transferring into a secondary urine specimen container for subsequent analysis and/or other investigation in a laboratory. It is typically in the form of a bowl-shaped container, divided into sections, with a pouring spout for emptying and/or transferring the urine specimen into a secondary container. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NNI	Container, Specimen, Non-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: 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: c9ac8fa2-9756-4e89-b1db-0a4d1955b058
Public Version Date: September 20, 2024
Public Version Number: 1
DI Record Publish Date: September 12, 2024