FDA UDI
In Commercial Distribution
🇺🇸 United States
ZEPHYR,800,10,PUFF,JERON 680
DI: 00840828195966
·
Model: GEB-19C0-203A-N
·
CURBELL MEDICAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ZEPHYR,800,10,PUFF,JERON 680
- Primary DI
- 00840828195966
- Version / Model
- GEB-19C0-203A-N
- Catalog Number
- 30551
- Company Name
- CURBELL MEDICAL PRODUCTS, INC.
- Labeler DUNS
- 796452311
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-02-11
- Public Version
- 1
- Public Version Date
- 2026-02-19
- Public Version Status
- New
- Public Device Record Key
- a343f29d-0aa1-40ba-8006-31c08d47654e
Device Description
ZEPHYR,800,10,PUFF,JERON 680
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ILQ | System, Communication, Powered | Physical Medicine | 890.3710 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62167 | Fixed call button | A battery-powered electronic switch intended to initiate an alert signal for help when manually activated by a user in response to a need of assistance (e.g., general care, low insulin levels). It typically consists of a bedside, wall-affixed, push-button or pull-cord, wireless radio-frequency transmitter which activates a nurse call or home alert system communication device (e.g., central server, phone, pager) to notify a medical professional, caregiver, neighbour, or emergency medical services (EMS) that assistance is needed. It is intended to be used in the home and healthcare facility. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840828195966 | GS1 |
Customer Contacts
- Phone
- 1-800-235-7500
- [email protected]