AccessGUDID - DEVICE: AincA® (B00500112P0)

GUDID

Device Identifier (DI) Information

Brand Name: AincA®
Version or Model: 00-112-P
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00-112-P
Company Name: ANESTHESIA ASSOCIATES, INC.

Primary DI Number: B00500112P0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002065670 *Terms of Use

Device Description: Adapter Kit, Plug Safety Retrofit, for Pre-Year-2000 (00-100) Nerve Stimulators, w/Tools

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":	Yes
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?
35722	Block-monitoring peripheral nerve electrical stimulation system	An assembly of battery-powered devices designed to apply electrical stimuli to a peripheral nerve (e.g., the ulnar or lower extremity nerve) to assess the adequacy of neuromuscular block during surgery, and its reversal during the recovery period. The system typically uses four kinds of stimulation: twitch, train-of-four, tetanic, and double burst. It typically includes conventional electrocardiographic electrodes and/or bipolar surface electrodes (ball electrodes), and a pulse generator.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BXN	STIMULATOR, NERVE, BATTERY-POWERED

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K811614	000

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: d4a28ef2-5848-4bfb-9c18-99872aa0809f
Public Version Date: April 08, 2021
Public Version Number: 1
DI Record Publish Date: March 31, 2021