| Primary Device ID | 10732671102338 |
| NIH Device Record Key | 321b8381-44db-433f-b1b0-1cc1786eb0a2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PIP |
| Version Model Number | 202TK |
| Catalog Number | 202TK |
| Company DUNS | 016069284 |
| Company Name | AMITY HOLDINGS, LLC |
| 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 | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00732671002334 [Primary] |
| GS1 | 10732671102338 [Package] Contains: 00732671002334 Package: Box [200 Units] In Commercial Distribution |
| GS1 | 20732671202332 [Package] Package: Inner Case [24 Units] In Commercial Distribution |
| GS1 | 30732671302336 [Package] Contains: 20732671202332 Package: Master Case [6 Units] In Commercial Distribution |
| FMK | Lancet, Blood |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-03-08 |
| Device Publish Date | 2024-02-29 |
| 10732671109351 | Lancing Device with Ejector |
| 20732671209348 | 33ga Twist Lancets |
| 30732671309335 | Insulin Pen Needle 31ga X 6.0mm |
| 30732671309328 | Insulin Pen Needle 31ga X 5.0mm |
| 30732671309311 | Insulin Pen Needle 32ga X 4.0mm |
| 00732671009036 | Safety Lancet |
| 00732671009029 | Safety Lancet |
| 00732671009012 | Safety Lancet |
| 60732671609030 | PIP Trial Pack: 30ea 903; 10ea 901; 10ea 902 |
| 60732671609023 | PIP Trial Pack: 30ea 902; 10ea 901; 10ea 903 |
| 60732671609016 | PIP Lancet Trial Pack: 30ea 901; 10ea 902; 10ea 903 |
| 10732671209426 | Glucose Control Solutions L1(Low) and L2 (High) - 2 Vials 2.5dL each |
| 00732671109422 | Control Solution - L2 (High) |
| 00732671009425 | Control Solution - L1 (low) |
| 00732671009418 | Blood Glucose Test Strips |
| 00732671009401 | Blood Glucose Test Meter |
| 10732671102338 | 28G Lancet |