| Primary Device ID | 08720387388059 | 
| NIH Device Record Key | af721cff-d6f6-49dc-8793-c7dcbbe1ba29 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | AFCS PEARLS™ Filter sheet small multifilament | 
| Version Model Number | SAT2 | 
| Catalog Number | 2010604 | 
| Company DUNS | 417294923 | 
| Company Name | Synergie Nederland B.V. | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | true | 
| 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 | false | 
| Serial Number | false | 
| Manufacturing Date | false | 
| Expiration Date | false | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | false | 
| OTC Over-The-Counter | false | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 08720387388059 [Primary] | 
| INX | Bed, Air Fluidized | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2021-08-30 | 
| Device Publish Date | 2021-08-20 | 
| 08720387388004 - AFCS PEARLS™ Control unit | 2021-08-30 Air-Fluidized bed - see www.synergiecare.com AFCS PEARLS™ (SAT2) Innovative care Control Unit | 
| 08720387388011 - AFCS PEARLS™ Bed unit | 2021-08-30 Air-Fluidized bed - see www.synergiecare.com AFCS PEARLS™ (SAT2) Innovative care Bed/Frame | 
| 08720387388028 - AFCS PEARLS™ Extension Hose | 2021-08-30 Air-Fluidized bed - see www.synergiecare.com Extension hose to place the control unit seperate from the bed unit | 
| 08720387388035 - AFCS PEARLS™ Air filter | 2021-08-30 Air-Fluidized bed - see www.synergiecare.com AFCS PEARLS™ (SAT2) Air filter | 
| 08720387388042 - AFCS PEARLS™ Filter sheet large multifilament | 2021-08-30 Air-Fluidized bed - see www.synergiecare.com AFCS PEARLS™ (SAT2) Filter sheet large multifilament | 
| 08720387388059 - AFCS PEARLS™ Filter sheet small multifilament | 2021-08-30Air-Fluidized bed - see www.synergiecare.com AFCS PEARLS™ (SAT2) Filter sheet small multifilament | 
| 08720387388059 - AFCS PEARLS™ Filter sheet small multifilament | 2021-08-30 Air-Fluidized bed - see www.synergiecare.com AFCS PEARLS™ (SAT2) Filter sheet small multifilament | 
| 08720387388066 - AFCS PEARLS™ Filter sheet large monofilament | 2021-08-30 Air-Fluidized bed - see www.synergiecare.com AFCS PEARLS™ (SAT2) Filter sheet large monofilament | 
| 08720387388073 - AFCS PEARLS™ Filter sheet small monofilament | 2021-08-30 Air-Fluidized bed - see www.synergiecare.com AFCS PEARLS™ (SAT2) Filter sheet small monofilament |