AccessGUDID - DEVICE: Tablo(R) Straws (00850001011136)

GUDID

Device Identifier (DI) Information

Brand Name: Tablo(R) Straws
Version or Model: PN-0004211
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Outset Medical, Inc.

Primary DI Number: 00850001011136
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:	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?
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: 4e4e1a42-5cd6-4eca-8743-f740281cdebe
Public Version Date: May 14, 2025
Public Version Number: 2
DI Record Publish Date: August 03, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10850001011133	50	00850001011136		In Commercial Distribution	cardboard box

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 844.698.2256
Email: TechnicalService@outsetmedical.com

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