AccessGUDID - DEVICE: N/A (10841898130854)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: N/A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NRG-E-HF-98-C1
Company Name: INNOVATIVE HEALTH LLC

Primary DI Number: 10841898130854
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 015575953 *Terms of Use

Device Description: Reprocessed NRG Transseptal Needle, 98 cm

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?
65069	Cardiac transseptal access electrosurgical catheter, reprocessed	A flexible tube intended to be used during a transseptal catheterization procedure to: 1) apply radio-frequency alternating current in a monopolar configuration, to puncture the interatrial septum and gain access to the left atrium; and 2) provide a fluid path to facilitate aspiration, injection/infusion, blood sampling, and/or pressure monitoring; it is not intended for cardiac ablation or to accommodate a needle in its lumen. It has a distal monopolar electrode. This is a previously used single-use device that has been processed for an additional single-use patient application.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QLZ	Septostomy Catheter, Reprocessed

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K200060	000
K213584	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a476259a-893e-4a08-8d09-3e6cc313df70
Public Version Date: February 09, 2024
Public Version Number: 2
DI Record Publish Date: September 24, 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
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: No
Serial Number: Yes
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 877-400-3740
Email: regulatory@innovative-health.com

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