medipines.comMediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly
MediPines Corporation
MEDIPIN at JHS
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3004893971 | 3004893971 | MEDIPIN at JHS | 1 | N | 2026-01-01 | Denby High Road Ware Hertfordshire GB SG11 1AF |
| 3015272694 | 3015272694 | MEDIPINES CORPORATION | 1 | N | 2026-01-01 | 22755 Savi Ranch Pkwy Ste C Yorba Linda CA US 92887 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00860001261509 | MediPines Gas Exchange Monitor - The MediPines Gas Exchange Monitor (GEM) is a non-invasive, multi-parameter respiratory monitoring device that provides spot-check respiratory gas measurements of oxygen (PO2, ETO2) and carbon dioxide (PCO2, ETCO2) from breathing, respiration rate (RR), functional saturation of arterial hemoglobin (SpO2), pulse rate (PR), and a range of other calculated indices. | 9493984670 | contact@medipines.com |
| 00860001261516 | MediPines Single Patient Use Breathing Circuit - Breathing Circuit Kit, Single Patient Use, 10 | 9493984670 | contact@medipines.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 226861 | 1836266264 | K180902 | MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly | CCK | 2019-01-11 |
| 64445 | 1269802851 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| CCK | 1 | 2019-01-11 |
PMN#
GUDID#
Medipin - A box of 100 Single-Use Protected Neurological Pins - A disposable precision esthesiometer for testing cutaneous pinprick sensation designed to optimise the patient's perception of sharpness without piercing delicate skin for use in the clinical or non-clinical setting. GMDN Definition: A hand-held manual pin-like device with a sharp distal end intended to be used to test for the presence of pain (pin prick) sensation in the skin. A healthcare professional uses the device to touch the skin of a patient who provides a response based on the sensation experienced; the device may have a safety feature to prevent unintentional injury. This is a single-use device.
2021-03-25
Medipin - A carton of 12 Single-Use Protected Neurological Pins intended to allow patients with diabetes to test themselves safely at home monthly for early signs of diabetic neuropathy according to American Diabetes Association guidelines - A disposable precision esthesiometer for testing cutaneous pinprick sensation designed to optimise the patient's perception of sharpness without piercing delicate skin for use in the clinical or non-clinical setting. GMDN Definition: A hand-held manual pin-like device with a sharp distal end intended to be used to test for the presence of pain (pin prick) sensation in the skin. A healthcare professional uses the device to touch the skin of a patient who provides a response based on the sensation experienced; the device may have a safety feature to prevent unintentional injury. This is a single-use device.
2021-03-25
MediPines Gas Exchange Monitor Starter Kit - Breathing Circuit and Nose Clip, Single Use, 10 pieces each
2019-03-25
MediPines Single Patient Use Breathing Circuit - Breathing Circuit Kit, Single Patient Use, 10
2019-03-25
MediPines Gas Exchange Monitor - The MediPines Gas Exchange Monitor (GEM) is a non-invasive, multi-parameter respiratory monitoring device that provides spot-check respiratory gas measurements of oxygen (PO2, ETO2) and carbon dioxide (PCO2, ETCO2) from breathing, respiration rate (RR), functional saturation of arterial hemoglobin (SpO2), pulse rate (PR), and a range of other calculated indices.
2019-03-25