AccessGUDID - DEVICE: Fisherbrand (00613647009277)

GUDID

Device Identifier (DI) Information

Brand Name: Fisherbrand
Version or Model: 3841PL-FH
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 23555801
Company Name: FISHER SCIENTIFIC COMPANY L.L.C.

Primary DI Number: 00613647009277
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 004321519 *Terms of Use

Device Description: FB STRAW URINE XFER NS 100/PK

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?
58157	Urine transfer IVD, non-sterile	A non-sterile plastic adaptor or dedicated transfer device, intended to be used to assist with the transfer of a urine specimen from the primary collection container to an evacuated urine specimen container for subsequent analysis and/or other investigation. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXG	EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE

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: af7ceadc-a0c6-4823-83f1-e1ec9e29b38e
Public Version Date: December 07, 2022
Public Version Number: 1
DI Record Publish Date: November 29, 2022