| Primary Device ID | 04716770935003 |
| NIH Device Record Key | 3f478f23-5081-4185-a99a-ee31d32da15c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | INCENTIVE SPIROMETER,5000ML |
| Version Model Number | TB-93500 |
| Company DUNS | 658023775 |
| Company Name | BESMED HEALTH BUSINESS CORP. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| 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 | 04716770935003 [Primary] |
| BWF | Spirometer, Therapeutic (Incentive) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-06 |
| 04716770701127 - HME W/Luer lock port (Dead space 45ml) | 2026-02-19 HME W/Luer lock port (Dead space 45ml) |
| 04716770701158 - Angled HME with luer lock port | 2026-02-19 Angled HME with luer lock port |
| 04716770702230 - Bacterial Filter (Dead space 32ml) | 2026-02-19 Bacterial Filter (Dead space 32ml) |
| 14716770703029 - HMEF W/Luer lock port (Dead space 45ml) | 2026-02-19 HMEF W/Luer lock port (Dead space 45ml) |
| 14716770703036 - HMEF W/Luer lock port (Dead space 60ml) | 2026-02-19 HMEF W/Luer lock port (Dead space 60ml) |
| 14716770703067 - HMEF (Dead space 60ml) | 2026-02-19 HMEF (Dead space 60ml) |
| 04716770834221 - ICU gas sampling pack | 2022-08-16 OEM ref: C05096-01-11 |
| 04716770834238 - ICU gas sampling pack with flowmeter | 2022-08-16 OEM ref: C05096-02-11 |