AccessGUDID - DEVICE: nGEN Pump (10846835017472)

GUDID

Device Identifier (DI) Information

Brand Name: nGEN Pump
Version or Model: D139702
Commercial Distribution Status: In Commercial Distribution
Catalog Number: D139702
Company Name: Biosense Webster Inc

Primary DI Number: 10846835017472
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 020163218 *Terms of Use

Device Description: Irrigation Pump

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:	No
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?
60784	Cardiac radio-frequency ablation system generator	An electrically-powered, noninvasive device intended to be used to generate radio-frequency energy to create ablative lesions in the cardiac tissue of a beating heart in the treatment of cardiac arrhythmias. The generator includes controls and may include electrocardiograph (ECG) interfacing/monitoring functionality. It may be intended to be used with a radio-frequency catheter for endocardial ablation and/or an epicardial probe for epicardial ablation.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LBP	REPLACEMENT, OSSICULAR (STAPES) USING ABSORBABLE GELATIN MATERIAL
OAD	catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
DRF	CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
OAE	Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P990071	037
P990071	042
P990071	044

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep out of direct sunlight
Special Storage Condition, Specify: Keep Dry
Special Storage Condition, Specify: Do not use if package is damaged

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 04e2737b-8953-4ff4-b5d4-a023522af303
Public Version Date: June 17, 2022
Public Version Number: 1
DI Record Publish Date: June 09, 2022

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: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)729-9010
Email: RA-BWIUS-Complaints@its.jnj.com

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