Jedmed
Tubing Hanger Lvcb W/ Auto Suct/ Pres
1manufacturer
75catalogue numbers in this listing
17510(k) clearances naming this product code
Who Else Makes It
Registered in Anhui.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Anhui Shiyin Photoelectric Instrument Co., Ltd. | Suzhou | Anhui | Specification developer | 18 |
Record
| Listed by | Jedmed Instrument Company, United States |
|---|---|
| FDA product code | ETF |
| Device type | Unit, Examining/Treatment, Ent |
| Device class | Class 1 |
| Regulation | 21 CFR 874.5300 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-07-16 |
| Record revised | 2025-09-24 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 03-6152 | In distribution | |
| 03-6175 | In distribution | |
| 03-6154-L | In distribution | |
| 03-5856 | In distribution | |
| 03-6151 | In distribution | |
| 03-6150 | In distribution | |
| 03-6205-L | In distribution | |
| 03-6163-L | In distribution | |
| 03-6204 | In distribution | |
| 03-6172 | In distribution | |
| 03-6151-L | In distribution | |
| 03-6183 | In distribution | |
| 03-6200 | In distribution | |
| 03-6111 | In distribution | |
| 03-6202 | In distribution | |
| 03-6165-L | In distribution | |
| 03-6203 | In distribution | |
| 03-6005 | In distribution | |
| 03-5550 | In distribution | |
| 03-6162 | In distribution | |
| 03-6155 | In distribution | |
| 03-6031 | In distribution | |
| 03-6185 | In distribution | |
| 03-6161-L | In distribution | |
| 03-6160-PL | In distribution | |
| 03-6000 | In distribution | |
| 03-6160-P | In distribution | |
| 03-6203-L | In distribution | |
| 03-6038 | In distribution | |
| 03-6204-L | In distribution | |
| 03-6182 | In distribution | |
| 03-6110 | In distribution | |
| 03-6171 | In distribution | |
| 03-5828 | In distribution | |
| 03-6030 | In distribution | |
| 03-6163 | In distribution | |
| 03-6161 | In distribution | |
| 03-6026 | In distribution | |
| 03-6165 | In distribution | |
| 03-6240 | In distribution | |
| 03-6196 | In distribution | |
| 03-6000-1 | In distribution | |
| 03-6174 | In distribution | |
| 03-6113 | In distribution | |
| 03-6181 | In distribution | |
| 03-6202-L | In distribution | |
| 03-7570 | In distribution | |
| 03-6115 | In distribution | |
| 03-7576 | In distribution | |
| 03-6150-API-1 | In distribution | |
| 03-6150-L | In distribution | |
| 03-6201-L | In distribution | |
| 03-6155-L | In distribution | |
| 03-6160 | In distribution | |
| 03-5528 | In distribution | |
| 03-6160-L | In distribution | |
| 03-6164-L | In distribution | |
| 03-7571 | In distribution | |
| 03-6201 | In distribution | |
| 03-6170 | In distribution | |
| 03-6184 | In distribution | |
| 03-6153 | In distribution | |
| 03-6194 | In distribution | |
| 03-6150-API | In distribution | |
| 03-6180 | In distribution | |
| 03-6036 | In distribution | |
| 03-7575 | In distribution | |
| 03-6154 | In distribution | |
| 03-6152-L | In distribution | |
| 03-6153-L | In distribution | |
| 03-6200-L | In distribution | |
| 03-6173 | In distribution | |
| 03-6162-L | In distribution | |
| 03-6205 | In distribution | |
| 03-6164 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Atmos | Atmos Medizintechnik Gmbh & Co. KG | 18 |
| MTI | Tech Industries. Inc. | 17 |
| BR Surgical, LLC | BR Surgical LLC | 17 |
| SMR Maxi Cabinet, Aluminum Composite, Standard-Tall, Corded Otoscopes, Canada | Global Surgical Corp. | 9 |
| SMR Maxi Cabinet, Aluminum Composite, Deluxe-Tall, NO Otoscopes | Global Surgical Corp. | 9 |
| Optomic | Optomic España SA | 7 |
| Otopront | Happersberger Otopront Gmbh | 6 |
| Disposable Hydrophobic Hepa Filter FOR Cabinet Suction Line – 6 Pack | Global Surgical Corp. | 4 |
| Reliance | Haag-Streit USA, Inc. | 4 |
| SMR Maxi Cabinet, Aluminum Composite, Standard, Corded Otoscopes, 220-240V, Requ | Global Surgical Corp. | 3 |
| SMR Maxi Cabinet, Stainless Steel, Standard, NO Otoscopes | Global Surgical Corp. | 3 |
| SMR Maxi Cabinet, Stainless Steel, Deluxe-Tall, Rechargeable Otoscopes | Global Surgical Corp. | 3 |
Showing 12 of 81. All products under Unit, Examining/Treatment, Ent
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K953457 | 1995-08-11 |
| K910243 | 1991-04-17 |
| K896273 | 1990-01-26 |
| K896298 | 1990-01-26 |
| K881958 | 1988-07-15 |
| K855021 | 1986-03-20 |
| K833882 | 1984-01-27 |
| K810148 | 1981-02-17 |
| K802712 | 1980-11-26 |
| K801738 | 1980-08-13 |
| K801740 | 1980-08-13 |
| K801742 | 1980-08-13 |
| K801741 | 1980-08-13 |
| K801739 | 1980-08-13 |
| K791936 | 1979-10-30 |
| K791934 | 1979-10-30 |
| K791935 | 1979-10-30 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.