| Primary Device ID | 00816472022811 |
| NIH Device Record Key | 416d7c83-eb11-403a-8623-fbde93ab19bc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FIXED MASK ELBOW WITH LUER LOCK CONNECTION |
| Version Model Number | 21536500 |
| Company DUNS | 785952607 |
| Company Name | Intersurgical Incorporated |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| 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 | 00816472022804 [Primary] |
| GS1 | 00816472022811 [Package] Contains: 00816472022804 Package: [50 Units] In Commercial Distribution |
| BZA | Connector, Airway (Extension) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-28 |
| Device Publish Date | 2023-06-20 |
| 05030267033669 - 22MM FLEXTUBE DUAL HEATED WIRE BREATHING SYSTEM WITH EXTRA LIMBS.>1.6M | 2025-03-24 22MM FLEXTUBE DUAL HEATED WIRE BREATHING SYSTEM WITH EXTRA LIMBS. > 1.6M |
| 05030267097913 - 22MM FLEXTUBE DUAL H/W B/S WITH AUTO-FILL CHAMBER AND EXTRA LIMBS. >1.6M | 2025-03-24 22MM FLEXTUBE DUAL HEATED WIRE BREATHING SYSTEM WITH AUTO-FILL CHAMBER AND EXTRA LIMBS. > 1.6M |
| 05030267033683 - 22MM SMOOTHBORE SINGLE H/W BREATHING SYSTEM WITH WATER TRAP AND LIMB.>1.6M | 2025-03-24 22MM SMOOTHBORE SINGLE HEATED WIRE BREATHING SYSTEM WITH WATER TRAP AND LIMB. > 1.6M |
| 05030267096374 - 22MM SMOOTHBORE SINGLE H/W B/S WITH WATER TRAP,AUTO-FILL CHAMBER,EXTRA LIMB>1.6M | 2025-03-24 22MM SMOOTHBORE SINGLE HEATED WIRE BREATHING SYSTEM WITH WATER TRAP, AUTO-FILL CHAMBER AND EXTRA LIMB. > 1.6M |
| 05030267033676 - 22MM SMOOTHBORE DUAL H/W BREATHING SYSTEM WITH EXTRA LIMB. > 1.6M | 2025-03-24 22MM SMOOTHBORE DUAL HEATED WIRE BREATHING SYSTEM WITH EXTRA LIMB. > 1.6M |
| 05030267167678 - UNIVERSAL STYLET BOUGIE (USB) WITHOUT SACHET OF LUBRICANT | 2025-03-24 UNIVERSAL STYLET BOUGIE (USB) WITHOUT SACHET OF LUBRICANT |
| 05030267161928 - 22MM FLEXTUBE SINGLE H/W LIMB WITH AUTO-FILL CHAMBER AND EXTRA LIMB.>1.6M | 2025-03-24 22MM FLEXTUBE SINGLE HEATED WIRE LIMB WITH AUTO-FILL CHAMBER AND EXTRA LIMB. > 1.6M |
| 00816472020435 - Filta-Therm™ HMEF with luer port, retainable cap and Flextube™ | 2025-02-11 Filta-Therm™ HMEF with luer port, retainable cap and Flextube™ |