| Primary Device ID | 17290109153985 |
| NIH Device Record Key | 0066f50a-e2f5-498b-97a5-fb1094fd9515 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Infusion Pouch 500mL |
| Version Model Number | 05080-605-0001 |
| Company DUNS | 533108028 |
| Company Name | Q-CORE MEDICAL LTD |
| 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 | true |
| Manufacturing Date | true |
| 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 | 17290109153985 [Primary] |
| MRZ | Accessories, Pump, Infusion |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-11-14 |
| Device Publish Date | 2022-11-06 |
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| 17290109153985 - Infusion Pouch 500mL | 2022-11-14 |
| 17290109153985 - Infusion Pouch 500mL | 2022-11-14 |
| 17290109154043 - Homecare Large Backpack | 2022-11-14 |
| 17290109154050 - Communication Cable -US | 2022-11-14 |
| 27290109153937 - Multi-Pump Bracket Kit - US (4 units) | 2022-11-14 |
| 27290109154071 - Multi-Pump Mounting System compatible with IPS- A | 2022-05-24 |
| 17290109153046 - AP403-01 - MICROBORE WITH VENTED/NON-VENTED SPIKE | 2022-05-23 |
| 27290109153067 - AP409-01 PRIMARY INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER, BACK CHECK VA | 2022-05-23 |