AccessGUDID - DEVICE: Balt Aspiration Tubing Set (00810068563986)

GUDID

Device Identifier (DI) Information

Brand Name: Balt Aspiration Tubing Set
Version or Model: BASPT-110
Commercial Distribution Status: In Commercial Distribution
Catalog Number: N/A
Company Name: BALT USA LLC

Primary DI Number: 00810068563986
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 945543689 *Terms of Use

Device Description: The Balt Aspiration Tubing Set is intended to connect the Raptor Aspiration Catheter to the canister of a compatible aspiration pump and to allow the user to control the fluid flow.

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?
58173	Thrombectomy suction catheter	A flexible or semi-flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction in native/stented blood vessels, native/synthetic bypass grafts, and/or haemodialysis access grafts, through suction (aspiration) in conjunction with a syringe or dedicated suction pump system (pump not included). It may additionally be intended for infusion of fluids and/or used as a guide-catheter to facilitate introduction of a thrombectomy wire-net (not included) to remove residual thrombus. Collection containers may be included with the catheter. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NRY	Catheter, Thrombus Retriever

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Special Storage Condition, Specify: Store the Balt Aspiration Tubing Set in a cool, dry place.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Length: 114”
Device Size Text, specify: Inner Diameter: 0.110” ± 0.003”

Device Record Status

Public Device Record Key: 0ba13c0c-bd79-4c7a-a1d4-6d51f0f2e923
Public Version Date: June 05, 2025
Public Version Number: 2
DI Record Publish Date: May 27, 2025