AccessGUDID - DEVICE: Clinical Station Kit (00852184003250)

GUDID

Device Identifier (DI) Information

Brand Name: Clinical Station Kit
Version or Model: 20-0038
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Synapse Biomedical, Inc.

Primary DI Number: 00852184003250
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 138432070 *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":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
47813	Intramuscular diaphragm/phrenic nerve electrical stimulation system programmer	A battery-powered external device used by a healthcare professional to change, telemetrically, one or more of the operating parameters (the programs) of an intramuscular diaphragm/phrenic nerve electrical stimulation system external pulse generator (EPG). It reads transmitted parameters from the EPG providing historic and/or current information regarding the system performance so that the healthcare professional can make the necessary adjustments to the operating parameters of the EPG. It may also include a built-in printer or download data to other storage/printing devices.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OIR	Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator

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: No
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: 4f01dae1-64a1-41e9-99d5-6ed09d8aa9c6
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 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: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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