AccessGUDID - DEVICE: Park (00827002034327)

GUDID

Device Identifier (DI) Information

Brand Name: Park
Version or Model: G03432
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PBS-300
Company Name: COOK INCORPORATED

Primary DI Number: 00827002034327
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 042823948 *Terms of Use

Device Description: Park Blade Septostomy Catheter

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):	Yes
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?
47101	Cardiac septostomy catheter, blade	A flexible tube with a collapsible blade at the distal end that, once in situ, can be raised to an acute angle by the surgeon operating an actuation lever at the proximal end for a blade atrial septostomy (BAS) procedure. It is used to enlarge the interatrial opening in cases of mitral atresia (a septal defect found in the hearts of infants) or unsuccessful or insufficient balloon atrial septostomy. This procedure allows interatrial blood mixing in infants with congenital cardiac malformations. It is typically made of plastic and high-grade stainless steel materials. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXF	CATHETER, SEPTOSTOMY

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 in dark, dry, cool place.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f7db47c7-5bc8-4748-b1d8-ff50d7eaf423
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(812)330-5494
Email: sharedservices@cookmedical.com

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