AccessGUDID - DEVICE: Tablo Cartridge (00850001011075)

GUDID

Device Identifier (DI) Information

Brand Name: Tablo Cartridge
Version or Model: PN-0002305
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: CART-200
Company Name: Outset Medical, Inc.

Primary DI Number: 00850001011075
Issuing Agency: GS1
Commercial Distribution End Date: August 03, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 788744477 *Terms of Use

Device Description: Tablo Cartridge with Needleless Infusion Ports

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?
34999	Haemodialysis blood tubing set, single-use	A collection of tubing segments and associated devices (e.g., connectors, clamps) intended to be used to transfer blood between a patient's vascular access device and a haemodialyser during haemodialysis; it is sometimes referred to as haemodialysis blood lines. 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 [?]
K140841	000

Device Exempt from Premarket Submission: No 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
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between 5 and 40 Degrees Celsius
Special Storage Condition, Specify: Store in a clean, dry, indoor location

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 16e3788a-59da-4686-b9cb-14c4f1ed7f2c
Public Version Date: May 14, 2025
Public Version Number: 7
DI Record Publish Date: April 11, 2017