AccessGUDID - DEVICE: PA 10 (04035479131609)

GUDID

Device Identifier (DI) Information

Brand Name: PA 10
Version or Model: 394500
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 394500
Company Name: BIOTRONIK SE & Co. KG

Primary DI Number: 04035479131609
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315620229 *Terms of Use

Device Description: No description.

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":
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?
46842	Cardiac pulse generator analyser cable, single-use	An electrical conductor used to connect a pulse generator analyser to the leads of an implantable pulse generator (IPG) [i.e., an implantable pacemaker or automatic implantable cardioverter-defibrillator (AICD)] to test the function of the generator during the implantation procedure. It is typically an assembly of insulated wires (e.g., 2-4 meters in length) that terminate into several leads, each having a connector (e.g., an alligator clip) that connects to the implantable pacing leads (e.g., IS-1 leads) of the pulse generator, and with a connector at the proximal end that connects either directly or via an adaptor to the pulse generator analyser. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
NVY	Permanent defibrillator electrodes

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P980023	057

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
Storage Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Temperature: between 32 and 131 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: be6a8c5c-8ce7-4a76-ace9-001e35908f09
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 20, 2014

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(888)345-0374
Email: jon.brumbaugh@biotronik.com

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