| Primary Device ID | 00841447104308 |
| NIH Device Record Key | d7a14dcd-7858-480e-bf80-e8b2384965af |
| Commercial Distribution Discontinuation | 2019-05-07 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | PMI Probasics® |
| Version Model Number | 7700M |
| Catalog Number | 7700M |
| Company DUNS | 005249268 |
| Company Name | PMI |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 732-683-1900 |
| lrhodes@invacare.com | |
| Phone | 800-376-7263 |
| customerservice@compasshealthbrands.com | |
| Phone | 800-376-7263 |
| customerservice@compasshealthbrands.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841447104308 [Primary] |
| BZD | Ventilator, Non-Continuous (Respirator) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-05-08 |
| Device Publish Date | 2016-09-23 |
| 00841447104544 | Electrodes Pregelled (4 per package) |
| 00841447104537 | Lead wires for TENS unit |
| 00841447104285 | Tens Unit with accessories |
| 00841447104278 | 50 PSI Compressor |
| 00841447104261 | Suction Machine |
| 00841447104421 | Single Lumen O2 Conserver |
| 00841447104414 | STEALTH Nasal Pillows Interface |
| 00841447104407 | Zzz-Mask Full Face Mask - Large |
| 00841447104391 | Zzz-Mask Full Face Mask - Medium |
| 00841447104384 | Zzz-Mask Full Face Mask - Small |
| 00841447104377 | CPAP Full Face Mask Including Headgear -Large |
| 00841447104360 | CPAP Full Face Mask Including Headgear - Medium |
| 00841447104353 | CPAP Full Face Mask Including Headgear - Small |
| 00841447104346 | Zzz-Mask Nasal Mask - Large |
| 00841447104339 | Zzz-Mask Nasal Mask - Medium |
| 00841447104322 | Zzz-Mask Nasal Mask - Small |
| 00841447104315 | Nasal Mask with Headgear - Large |
| 00841447104308 | Nasal Mask with Headgear - Medium |
| 00841447104292 | Nasal Mask with Headgear - Small |
| 00841447104254 | Pediatric Pulse Oximeter - Panda |
| 00841447104247 | Pediatric Pulse Oximeter - Little Pig |
| 00841447104230 | Pediatric Pulse Oximeter - Little Frog |
| 00841447104223 | Digit-Ox III Finger Type Pulse Oximeter |
| 00841447104216 | Digit-Ox II Portable Finger Pulse Oximeter |
| 10841447104053 | Reusable Jet Nebulizer Set |
| 10841447104046 | Buddy the Dog Pediatric Compressor Nebulizer |
| 10841447104039 | Humphrey the Hippo Pediatric Nebulizer |
| 20841447104029 | Probasics Rite-Neb 4™ Nebulizer Compressor |
| 20841447104012 | Probasics Rite-Neb3 Mini Compressor Nebulizer |
| 00841447104575 | Full Electric Low Bed |
| 00841447104568 | Foot Spring Section with Motor for Single Motor Bed |
| 00841447104551 | Single Motor Semi-Electric Home Care Bed |
| 00841447104513 | Head and Foot Spring Sections for Single Motor Bed |
| 00841447104506 | Foot Spring, Foot Board, Motors for Full Electric Bed |
| 00841447104490 | Bed Ends for HB6 Bariatic Bed |
| 00841447104483 | Head Spring Section for HB6 Bariatric Bed |
| 00841447104476 | Foot Section with Motors for HB4 Bariatric Bed |
| 00841447104469 | Foot Spring Section for Two Motor Bed |
| 00841447104452 | Bariatric Half Rails |
| 00841447104445 | Half Length Bed Rails |
| 00841447104438 | Full Bed Rails |
| 00841447104209 | Full Electric Low Bed |
| 00841447104193 | Bed Ends for HB4 Bariatric Bed |
| 00841447104186 | Bariatric Bed |
| 00841447104179 | Bariatric Bed |
| 00841447104155 | Low Bed Ends Only |
| 00841447104148 | Bed Ends - Replacement parts for HBSM |
| 00841447104131 | Bed Ends - Replacement parts for HBSM |
| 00841447104124 | Single Motor Semi-Electric Home Care Bed |
| 00841447104070 | APP (Pads only) |