| Primary Device ID | 05099169284029 |
| NIH Device Record Key | 5b32fc40-4d7e-4dc6-b4be-85048025bb45 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PFT |
| Version Model Number | 2820 |
| Company DUNS | 219683489 |
| Company Name | VITALOGRAPH (IRELAND) LIMITED |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05099169284029 [Package] Contains: 15099169284026 Package: [50 Units] In Commercial Distribution |
| GS1 | 15099169284026 [Primary] |
| GS1 | 55099169284024 [Package] Package: [12 Units] In Commercial Distribution |
| BZG | SPIROMETER, DIAGNOSTIC |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-03-23 |
| Device Publish Date | 2016-12-01 |
| 55099169285731 | 2820 ECO PFT KIT MS |
| 05099169285729 | 2820 Eco BVF + DNC |
| 05099169285712 | 2820 Eco BVF LAB + DNC |
| 05099169285521 | 2820 ECO BVF LAB |
| 05099169285507 | 2820 ECO BVF |
| 55099169284499 | 2820 BVF (28401) + DNC |
| 05099169284487 | 2820 BVF (FOSTER) + DNC + OVAL MP |
| 05099169284432 | 2820 BVF (KOKO) + DNC + FRONT BITE-ON |
| 05099169284425 | 2820 BVF (MED GR) + DNC + FRONT BITE-ON |
| 55099169284413 | 2820 BVF (JAE) + DNC + FRONT BITE-ON |
| 05099169284401 | 2820 BVF (SM,PKM,Ga) + DNC + FRONT BITE |
| 05099169284395 | 2820 BVF(28365) + 2020 REAR BITE-ON + 2030 DISP NOSE CLIP |
| 05099169284388 | 2820 BVF (28365) + 2030 DISP NOSE CLIP + OVAL MP |
| 05099169284371 | 2820 BVF (28368) + OVAL MOUTHPIECE |
| 55099169284369 | 2820 BVF (28368) + 2030 NOSE CLIP |
| 05099169284340 | 2820 PFT KIT |
| 05099169284326 | 30/30 PFT KIT |
| 05099169284319 | 2820 BVF (28362) + OVAL M/P + 2030 DISPOSABLE NOSE CLIP |
| 05099169284302 | 2820 BVF (28365) + OVAL M/P |
| 05099169284296 | 2820 BVF (28363) + OVAL M/P |
| 05099169284289 | 2820 BVF (28362) + OVAL M/P |
| 55099169284277 | 2820 BVF (28350) + OVAL M/P |
| 05099169284265 | 2820 PFT KIT 25ID |
| 05099169284258 | 2820 PFT KIT TRANSL. BVF FRONT-BITE |
| 55099169284215 | 2820 PFT KIT 30/30 |
| 05099169284180 | 2820 PFT KIT 30ID MEDISIZE |
| 55099169284048 | 2820 BV FILTER + OVAL M/P + 2030 NOSECLIP |
| 55099169284031 | 2820 BV FILTER (28363) + OVAL M/P + 2030 NOSE CLIP |
| 05099169284029 | 2820 BV FILTER (28350) + OVAL M/P + 2030 NOSE CLIP |
| 05099169284005 | 30/30 PFT KIT |
| 05099169283855 | 2820 BV FILTER(28363)+OVAL M/P+45 ELBOW+2030 NOSE CLIP |
| 05099169283824 | 2820 BVF PFT KIT 28363 |
| 55099169283812 | 2820 BV FILTER + 2030 NOSE CLIPS PFT KIT (28362) |
| 05099169283725 | 2820 BV FILTER + 2030 NOSE CLIPS (28362 + 20243) |
| 55099169283713 | 2820 BV FILTER + 2030 NOSE CLIPS (28363 + 20243) |
| 05099169283701 | 2820 BV FILTER + 2030 NOSE CLIPS (28350 + 20243) |
| 55099169285533 | 2820 ECO BVF WITH BITE LIP + DNC |
| 05099169285514 | 2820 ECO BVF + BITE-ON MOUTHPIECE +DNC |