623medical.comUTC 3mL Medication Cartridge
Gilero, LLC
Gilero, Inc
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3016733629 | 3016733629 | Gilero, Inc | 1 | N | 2026-01-01 | 158 Credle Street Pittsboro NC US 27312 |
| 3013401750 | 3013401750 | Gilero, LLC | 1 | N | 2020-04-25 | 635 Davis Dr Ste 100 Morrisville NC US 27560 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00850025535991 | NUM Vapocoolant - NUM is a sterile topical anesthetic spray – vapocoolant (skin refrigerant) intended for topical application to control pain associated with minor surgical procedures (such as lancing boils, incisions and drainage of small abscesses), injections (venipuncture, IV starts) and the temporary relief of minor sports injuries. | (877) 455-0112 | info@623medical.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 257578 | 1624561010 | K201936 | SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL | KPE | 2021-05-06 |
| 203224 | 1099269409 | ||||
| 257578 | 1644241372 | ||||
| 257578 | 1051802246 | ||||
| 257578 | 1099269409 | ||||
| 257578 | 1173301594 | ||||
| 257578 | 1266279667 | ||||
| 257578 | 1324255936 | ||||
| 257578 | 1380394294 | ||||
| 257578 | 1551466611 | ||||
| 257578 | 1651932242 | ||||
| 257578 | 1684699102 | ||||
| 257578 | 1766185166 | ||||
| 257578 | 1810815066 | ||||
| 257578 | 1817548427 | ||||
| 257578 | 2001271239 | ||||
| 257578 | 2041037409 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| KPE | 1 | 2021-05-06 |
PMN#
GUDID#
BD SmartSite Bag 250mL - The SmartSite Bag is an empty container used for administration of intravenous solutions to the patient using an intravascular administration set. Medication transfer in and out of the container is done using aseptic technique.
2023-12-01
BD SmartSite Bag 500mL - The SmartSite Bag is an empty container used for administration of intravenous solutions to the patient using an intravascular administration set. Medication transfer in and out of the container is done using aseptic technique.
2023-12-01
BD SmartSite Bag 100mL - The SmartSite Bag is an empty container used for administration of intravenous solutions to the patient using an intravascular administration set. Medication transfer in and out of the container is done using aseptic technique.
2023-12-01
BD SmartSite Bag 250mL - The SmartSite Bag is an empty container used for administration of intravenous solutions to the patient using an intravascular administration set. Medication transfer in and out of the container is done using aseptic technique.
2023-12-01
BD SmartSite Bag 500mL - The SmartSite Bag is an empty container used for administration of intravenous solutions to the patient using an intravascular administration set. Medication transfer in and out of the container is done using aseptic technique.
2023-12-01
UTC 3ml Medication Cartridge - UTC 3mL Medication Cartridge: The UTC 3 mL Medication Cartridge is intended for use in hospital and outpatient care environments with the CADD-MS®3 Ambulatory Infusion Pump for subcutaneous infusion of medication in adults
2023-09-25
NUM Vapocoolant - NUM is a sterile topical anesthetic spray – vapocoolant (skin refrigerant) intended for topical application to control pain associated with minor surgical procedures (such as lancing boils, incisions and drainage of small abscesses), injections (venipuncture, IV starts) and the temporary relief of minor sports injuries.
2021-06-04