AccessGUDID - DEVICE: Tablo(R) Straws (00850001011167)

GUDID

Device Identifier (DI) Information

Brand Name: Tablo(R) Straws
Version or Model: PN-0004378
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PN-0004467, PN-0005451
Company Name: Outset Medical, Inc.

Primary DI Number: 00850001011167
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 788744477 *Terms of Use

Device Description: Straws, for concentrate bottles

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:	No
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?
32110	Haemodialysis dialysate tubing, single-use	A sterile length of flexible tube, typically made of synthetic polymer material(s), intended to deliver haemodialysis dialysate and/or haemodialysis dialysate components (water, haemodialysis concentrate) to and/or from a haemodialysis machine/system. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FJK	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K190793	000

Device Exempt from Premarket Submission: No 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: 9ab63416-624c-4d32-a5be-aa7a79552794
Public Version Date: May 14, 2025
Public Version Number: 2
DI Record Publish Date: August 03, 2020