AccessGUDID - DEVICE: PTS-X™ (04046964512063)

GUDID

Device Identifier (DI) Information

Brand Name: PTS-X™
Version or Model: 613740
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 613740
Company Name: B BRAUN INTERVENTIONAL SYSTEMS, INC

Primary DI Number: 04046964512063
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 784259751 *Terms of Use

Device Description: PTSX253 PTSX BALLOON 25MM X 3CM X 80CM

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":	Yes
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?
42417	Cardiac sizing catheter	A sterile flexible tube with an inflatable balloon at the distal end designed for use in a patient with a cardiovascular defect wherein accurate measurement of the defect is important to select the appropriately sized occlusion device. It is typically designed to pass over a guidewire and it will have radiopaque marker bands along it distal end to assist in placement using fluoroscopy. It is made of plastic materials and metal [e, g, platinum (Pt) for the bands] and is available in a variety of designs and sizes. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MJN	Catheter, intravascular occluding, temporary

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K041306	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
Special Storage Condition, Specify:
Special Storage Condition, Specify: Store at room temp
Special Storage Condition, Specify: Keep away from sunlight
Special Storage Condition, Specify: KEEP DRY

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2d0e9e52-7244-457a-a9d0-fd93bd0a9711
Public Version Date: September 07, 2023
Public Version Number: 5
DI Record Publish Date: August 09, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

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: +1(877)836-2228
Email: GUDID.BBMUS_Service@bbraun.com

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