AccessGUDID - DEVICE: Propeller (00859105006055)

GUDID

Device Identifier (DI) Information

Brand Name: Propeller
Version or Model: Convenience Kit - HUB/SMII/SM2014-R
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: RECIPROCAL LABS CORPORATION

Primary DI Number: 00859105006055
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 968712278 *Terms of Use

Device Description: The convenience kit contains the following products: Propeller Sensor Model II (GTIN-14: 00865528000006) Propeller Sensor Model 2014-R (GTIN-14: 00865528000020) Qualcomm 2Net Hub (GTIN-14: 0100857803004014)

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
61866	Inhaler dose sensor	A small, non-sterile, battery-powered device intended to be attached to a portable inhaler [e.g., metered dose inhaler (MDI), dry powder inhaler (DPI), soft mist inhaler (SMI)] to detect when a dose of inhaled medication has been taken, and to transmit this data wirelessly to a separate device (e.g., smartphone with appropriate software) to evaluate dosing interval. It is typically used in conjunction with software that may, e.g., set reminders. This is a single-patient reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

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: 6179eb2e-9728-43a2-8f42-14006b350ced
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: July 22, 2016