FDA UDI
In Commercial Distribution
🇺🇸 United States
Propeller
DI: 00859105006284
·
Model: Convenience Kit - HUB/SM2016ML/SM2014R
·
RECIPROCAL LABS CORPORATION
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Propeller
- Primary DI
- 00859105006284
- Version / Model
- Convenience Kit - HUB/SM2016ML/SM2014R
- Company Name
- RECIPROCAL LABS CORPORATION
- Labeler DUNS
- 968712278
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-01-30
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- fb88d986-d2fa-4a3d-87d6-2ffd1aa07c34
Device Description
The convenience kit contains the following products: Propeller Sensor Model 2016-M-L (GTIN-14: 00865528000082) Propeller Sensor Model 2014-R (GTIN-14: 00865528000020) Qualcomm 2Net Hub (GTIN-14: 0100857803004014)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00859105006284 | GS1 |