| Primary Device ID | 04716770280035 |
| NIH Device Record Key | 50c097b0-ff8a-4010-8e00-b4a9fb910b24 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SINGLE USE NEONATE 180ML RESUSCITATOR W/RENDELL BA |
| Version Model Number | RE-28003 |
| 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 | 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 | 04716770280035 [Primary] |
| BTM | Ventilator, Emergency, Manual (Resuscitator) |
| 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 |
| 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 |
| 04716770144306 - Straight Connector 15F/22M, 15M W/PORT & CAP | 2021-01-15 |
| 04716770857398 - FLOW SENSOR, ADULT | 2021-01-15 |
| 04716770790015 - Elbow connetor 18MM ID for nebulizer | 2020-03-23 Elbow connetor 18MM ID for nebulizer |
| 04716770791043 - MOUTH PIECE (OD:18mm,22mm) | 2020-03-23 MOUTH PIECE (OD:18mm,22mm) |
| 04716770791081 - MOUTH PIECE(OD:22mm) | 2020-03-23 MOUTH PIECE(OD:22mm) |
| 04716770791098 - MOUTH PIECE (ID:18mm, OD:19.5mm) | 2020-03-23 MOUTH PIECE (ID:18mm, OD:19.5mm) |