Identity
- Trade Name
- AccuSert FDA UDI
- Generic Name
- Injector reset device FDA UDI
- Device Name
- SAF-SUB-Q Needle Inserter FDA UDI
- Model / Reference
- FP-0010080 FDA UDI
- Description
- SAF-SUB-Q Needle Inserter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817708022988 FDA UDI
- 510(k) Number
- K213429 FDA UDI
- FDA Product Code
- KZH FDA UDI
- GMDN Term
- Injector reset device FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6920 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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Injector reset device
AccuSert by EMED Technologies Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Injector reset device.
- Enlite® Serter — MEDTRONIC MINIMED, INC. · Class II
- Enlite™ Serter — MEDTRONIC MINIMED, INC. · Class III
- One-press Serter — MEDTRONIC MINIMED, INC. · Class III
- One-press Serter — MEDTRONIC MINIMED, INC. · Class III
- Minimed™ Quick-serter™ — MEDTRONIC MINIMED, INC. · Class II
- Sil-serter™ — MEDTRONIC MINIMED, INC. · Class II
- MiniMed™ Quick-serter™ — MEDTRONIC MINIMED, INC. · Class II
- Sil-serter™ — MEDTRONIC MINIMED, INC. · Class II
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- EMED Technologies Corporation
Sources (1)
- FDA UDI 57f890f6-807c-4e97-ab0d-7dd4cd84d403 34 fields · synced Jun 9, 2026