Identity
- Trade Name
- On Call Vivid Blood Glucose Monitoring System FDA UDI
- Generic Name
- Glucose monitoring system IVD, point-of-care FDA UDI
- Device Name
- Blood Glucose Monitoring System includes Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, 10 lancets (30G) FDA UDI
- Model / Reference
- G115-102 FDA UDI
- Description
- Blood Glucose Monitoring System includes Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, 10 lancets (30G) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00682607556113 FDA UDI
- 510(k) Number
- K112653 FDA UDI
- FDA Product Code
- JJX FDA UDICGA FDA UDINBW FDA UDI
- GMDN Term
- Glucose monitoring system IVD, point-of-care FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 FDA UDI862.1345 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Glucose monitoring system IVD, home-useGlucose monitoring system IVD, point-of-care
On Call Vivid Blood Glucose Monitoring System by ACON Laboratories, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Glucose monitoring system IVD, point-of-care.
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Cleared under the same submission
K112653 also covers:
- On Call Vivid Blood Glucose Meter — ACON Laboratories, Inc.
- On Call Vivid Blood Glucose Test Strips — ACON Laboratories, Inc.
- On Call Vivid Blood Glucose Test Strips — ACON Laboratories, Inc.
- On Call Vivid Blood Glucose Test Strips — ACON Laboratories, Inc.
- On Call Vivid Glucose Control Solution Kit — ACON Laboratories, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- ACON Laboratories, Inc.
Sources (1)
- FDA UDI 0816fbb7-12df-4d2e-82f0-4e83ae23bff8 36 fields · synced Jun 9, 2026