Identity
- Trade Name
- Pip FDA UDI
- Generic Name
- Glucose monitoring system IVD, home-use FDA UDI
- Device Name
- Blood Glucose Test Meter FDA UDI
- Model / Reference
- 940 FDA UDI
- Description
- Blood Glucose Test Meter FDA UDI
Identifiers
- Catalog Number
- 940 FDA UDI
- Primary DI / UDI-DI
- 00732671009401 FDA UDI
- 510(k) Number
- K113208 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Glucose monitoring system IVD, home-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Glucose monitoring system IVD, home-use
Pip by Amity Holdings, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Glucose monitoring system IVD, home-use.
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Cleared under the same submission
K113208 also covers:
- Pip — AMITY HOLDINGS, LLC
- Pip — AMITY HOLDINGS, LLC
- Pip — AMITY HOLDINGS, LLC
- Embrace EVO Control Solution, L1 (Low) — OMNIS HEALTH, LLC
- Embrace EVO Control Solution, L2 (Medium) — OMNIS HEALTH, LLC
- Embrace EVO Mini Meter, all-in-one kit, RETAIL — OMNIS HEALTH, LLC
- Embrace EVO Strips, 50ct Vial - RETAIL — OMNIS HEALTH, LLC
- EmbraceEVO Gestational Diabetes Package - LARGE (9 vials) — OMNIS HEALTH, LLC
- EmbraceEVO Gestational Diabetes Package - RETAIL (5 vials) — OMNIS HEALTH, LLC
- EmbraceEVO Gestational Diabetes Package - SMALL (5 vials) — OMNIS HEALTH, LLC
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
- Amity Holdings, Llc
Sources (1)
- FDA UDI ffde8c92-faae-4505-8d5c-9ffe10fc8420 36 fields · synced May 30, 2026