| Primary Device ID | 05030267118915 |
| NIH Device Record Key | d02c6912-7f8e-4053-a25f-db19defd48dc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | N/A |
| Version Model Number | RM21343 |
| Company DUNS | 785952607 |
| Company Name | INTERSURGICAL INCORPORATED |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00619498213436 [Primary] |
| GS1 | 05030267118908 [Package] Contains: 00619498213436 Package: [15 Units] In Commercial Distribution |
| GS1 | 05030267118915 [Package] Contains: 00619498213436 Package: [60 Units] In Commercial Distribution |
| BZA | Connector, Airway (Extension) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-24 |
| 05030267118915 | PAEDIATRIC CATHETER MOUNT 15M – 15F, 49 – 100MM |
| 05030267119011 | CORRUGATED CATHETER MOUNT 22F - 22M/15F DOUBLE FLIP TOP CAP,0.17M |
| 05030267118991 | SMOOTHBORE CATHETER MOUNT 22F - 22M/15F DOUBLE FLIP TOP CAP 0.18M |
| 05030267117321 | 22MM CORRUGATED SINGLE PATIENT CIRCUIT W/EXH VALVE 1.6M VSIII |
| 05030267117345 | 22MM CORRUGATED SINGLE PATIENT CIRCUIT W/EXH VALVE 1.6M ELISEE |
| 05030267115150 | 15MM CORRUGATED SINGLE PATIENT CIRCUIT W/EXH VALVE 1,6M W/TRAP 1.6M W/0.5M TUBE ASTRAL |
| 05030267115075 | 22MM CORRUGATED SINGLE PATIENT CIRCUIT W/EXH VALVE 1,6M W/TRAP W/0.5M TUBE ASTRAL |
| 05030267114429 | 30MM CORRUGATED COAXIAL CIRCUIT 1.6M |
| 05030267119110 | 15MM CORRUGATED SINGLE PATIENT CIRCUIT W/EXH VALVE 1.6M ASTRAL |
| 05030267114115 | 22MM CORRUGATED SINGLE PATIENT CIRCUIT W/EXH VALVE 1.6M ASTRAL |
| 05030267117178 | 15MM S/BORE SINGLE PATIENT CIRCUIT W/EXH VALVE 1.6M, VSIII |
| 05030267118144 | 22MM S/BORE SINGLE PATIENT CIRCUIT W/EXH VALVE 1.8M, VSIII |
| 05030267116218 | 15MM S/BORE SINGLE PATIENT CIRCUIT W/EXH VALVE 1.6M, ELISE |
| 05030267116232 | 22MM S/BORE SINGLE PATIENT CIRCUIT W/EXH VALVE 1.8M, ELISEE |
| 05030267114603 | 15MM S/BORE SINGLE PATIENT CIRCUIT W/EXH VALVE 1,6M W/TRAP W/0.5M TUBE, ASTRAL |
| 05030267117994 | 22MM S/BORE SINGLE PATIENT CIRCUIT W/EXH VALVE 1,8M W/TRAP W/0.5M TUBE, ASTRAL |
| 05030267114252 | 15MM S/BORE SINGLE PATIENT CIRCUIT W/EXH VALVE 1.6M, ASTRAL |
| 05030267120857 | 22MM S/BORE SINGLE PATIENT CIRCUIT WITH EXHALATION VALVE 1.8M, ASTRAL |
| 05030267114092 | 15MM CORRUGATED DOUBLE PATIENT CIRCUIT 1.6M |
| 05030267114191 | 22MM CORRUGATED DOUBLE PATIENT CIRCUIT 1.6M |
| 05030267114214 | 15MM CORRUGATED DOUBLE PATIENT CIRCUIT W/TRAPS 1.6M |
| 05030267114177 | 22MM CORRUGATED DOUBLE PATIENT CIRCUIT W/TRAPS 1.6M |
| 05030267114153 | 10MM S/BORE DOUBLE PATIENT CIRCUIT 1.6M |
| 05030267114238 | 15MM S/BORE DOUBLE PATIENT CIRCUIT 1.6M |
| 05030267114580 | 22MM S/BORE DOUBLE PATIENT CIRCUIT 1.8M |
| 05030267114542 | 15MM S/BORE DOUBLE PATIENT CIRCUIT W/TRAPS 1.6M |
| 05030267114078 | 22MM S/BORE DOUBLE PATIENT CIRCUIT W/TRAPS 1.8M |
| 05030267151561 | 22MM FLEXTUBE DUAL HEATED WIRE BREATHING SYSTEM WITH 0.5M LIMB, 1.6M LENGTH |
| 05030267151530 | 22MM FLEXTUBE DUAL HEATED WIRE BREATHING SYSTEM WITH AUTO-FILL CHAMBER AND 0.5M LIMB, 1.6M LENGT |
| 05030267140855 | 22mm Smoothbore breathing system with monitoring line and exhalation valve, 1.6m |
| 05030267140831 | 22mm Smoothbore breathing system with monitoring line and exhalation valve, 1.6m |
| 05030267140817 | 22mm Smoothbore breathing system with monitoring line and exhalation valve, single limb, 1.8m |
| 05030267140350 | 22MM SINGLE HEATED WIRE BREATHING SYSTEM |
| 05030267140336 | 22MM SINGLE HEATED WIRE BREATHING SYSTEM WITH AUTO FILL CHAMBER |
| 05030267139286 | INTER-THERM MINI PEDIATRIC HMEF STERILE |
| 05030267128273 | FACEFIT NIV MASK WITH PORT LARGE |
| 05030267128259 | FACEFIT NIV MASK WITH PORT MEDIUM |
| 05030267128235 | FACEFIT NIV MASK WITH PORT SMALL |
| 05030267117895 | FLO-GUARD BREATHING FILTER |
| 05030267109494 | INTER-THERM MINI PEDIATRIC ANGLED HMEF STERILE |
| 05030267096336 | DUAL HEATED WIRE BREATHING SYSTEM |
| 05030267106981 | HEATED WIRE SYSTEM WITH AUTO FILL CHAMBER |
| 05030267095865 | LOW VOLUME MANUAL FILL HUMIDIFICATION CHAMBER |
| 05030267095841 | MANUAL FILL HUMIDIFICATION CHAMBER |
| 05030267095827 | AUTO FILL HUMIDIFICATION CHAMBER |
| 05030267094493 | AIR-GUARD CLEAR FILTER |
| 05030267094479 | HYDRO-GUARD MINI FILTER/HME |
| 05030267084487 | CLEAR-GUARD II 99.99% EFFICIENT FILTER |
| 05030267084456 | CLEAR-THERM, 99.99% EFFICIENT FILTER/HME, LUER LOCK PORT |
| 05030267084432 | CLEAR-GUARD 3 BACTERIAL/VIRAL FILTER |