Identity
- Trade Name
- AUM FDA UDI
- Generic Name
- Manual blood lancing device, single-use FDA UDI
- Device Name
- AUM SAFETY PEN NEEDLES 32G -4MM FDA UDI
- Model / Reference
- SAFETY PEN NEEDLES 32G -4MM FDA UDI
- Description
- AUM SAFETY PEN NEEDLES 32G -4MM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00373317624512 FDA UDI
- 510(k) Number
- K210864 FDA UDI
- FDA Product Code
- FMI FDA UDI
- GMDN Term
- Manual blood lancing device, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Manual blood lancing device, single-use
Aum by Slv Pharmaceuticals LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Manual blood lancing device, single-use.
- neoheel — Sterilance Medical (Suzhou) Inc. · Class II
- Unistik 3 — OWEN MUMFORD LIMITED · Class II
- SurgiLance Lite Safety Lancet — MEDIPURPOSE PTE. LTD. · Class II
- AboutTime MPD 21Gx 1.8mm Safety Lancet — Medical Plastic Devices M.P.D. Inc · Class II
- EasyLife Pressure Activated Safety lancet 28G — CARE LIVING DIAGNOSTICS INC · Class II
- ONE-CARE OPTI Safety Lancets — MediVena, LLC · Class II
- GLUCO-CARE Safety Lancets 30G x 1.8 mm — MediVena, LLC · Class II
- STERiLANCE Press2 Disposable Safety Lancet — Sterilance Medical (Suzhou) Inc. · Class II
Cleared under the same submission
K210864 also covers:
- microdot® — Cambridge Sensors USA, LLC.
- ONE-CARE — MediVena, LLC
- EasyDrip ReadyGard Duo Safety Pen Needles 30G 6mm — Sandstone Medical (Suzhou) Inc.
- EasyDrip ReadyGard Duo Safety Pen Needles 31G 5mm — Sandstone Medical (Suzhou) Inc.
- Easydrip ReadyGard Duo Safety Pen Needles 30G×5mm — Sandstone Medical (Suzhou) Inc.
- Easydrip ReadyGard Duo Safety Pen Needles 31G×5mm — Sandstone Medical (Suzhou) Inc.
- Easydrip ReadyGard Duo Safety Pen Needles 31G×5mm — Sandstone Medical (Suzhou) Inc.
- Easydrip ReadyGard Safety Pen Needles 30G×5mm — Sandstone Medical (Suzhou) Inc.
- Easydrip ReadyGard Safety Pen Needles 30G×8mm — Sandstone Medical (Suzhou) Inc.
- Easydrip ReadyGard Safety Pen Needles 31G×8mm — Sandstone Medical (Suzhou) Inc.
- easydrip ReadyGard Duo Safety Pen Needles — Sandstone Medical (Suzhou) Inc.
- easydrip Readygard Duo Safety Pen Needles — Sandstone Medical (Suzhou) 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Slv Pharmaceuticals LLC
Sources (1)
- FDA UDI 2d634954-e2f1-4f44-906e-2ced78fffe46 34 fields · synced May 29, 2026