| Primary Device ID | 27290109150103 |
| NIH Device Record Key | 989b4ae7-5d22-49a1-9649-a886cdc6e321 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sapphire M.T. Infusion Kit- US |
| Version Model Number | 17000-028-0061 |
| Catalog Number | 17000-028-0061 |
| Company DUNS | 533108028 |
| Company Name | Q-CORE MEDICAL LTD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | 1-800-241-4002 |
| sapphireGCM@icumed.com | |
| Phone | 1-800-241-4002 |
| sapphireGCM@icumed.com | |
| Phone | 1-800-241-4002 |
| sapphireGCM@icumed.com | |
| Phone | 1-800-241-4002 |
| sapphireGCM@icumed.com | |
| Phone | 1-800-241-4002 |
| sapphireGCM@icumed.com | |
| Phone | 1-800-241-4002 |
| sapphireGCM@icumed.com | |
| Phone | 1-800-241-4002 |
| sapphireGCM@icumed.com | |
| Phone | 1-800-241-4002 |
| sapphireGCM@icumed.com | |
| Phone | 1-800-241-4002 |
| sapphireGCM@icumed.com | |
| Phone | 1-800-241-4002 |
| sapphireGCM@icumed.com | |
| Phone | 1-800-241-4002 |
| sapphireGCM@icumed.com | |
| Phone | 1-800-241-4002 |
| sapphireGCM@icumed.com | |
| Phone | 1-800-241-4002 |
| sapphireGCM@icumed.com | |
| Phone | 1-800-241-4002 |
| sapphireGCM@icumed.com | |
| Phone | 1-800-241-4002 |
| sapphireGCM@icumed.com | |
| Phone | 1-800-241-4002 |
| sapphireGCM@icumed.com | |
| Phone | 1-800-241-4002 |
| sapphireGCM@icumed.com | |
| Phone | 1-800-241-4002 |
| sapphireGCM@icumed.com | |
| Phone | 1-800-241-4002 |
| sapphireGCM@icumed.com | |
| Phone | 1-800-241-4002 |
| sapphireGCM@icumed.com | |
| Phone | 1-800-241-4002 |
| sapphireGCM@icumed.com | |
| Phone | 1-800-241-4002 |
| sapphireGCM@icumed.com | |
| Phone | 1-800-241-4002 |
| sapphireGCM@icumed.com | |
| Phone | 1-800-241-4002 |
| sapphireGCM@icumed.com | |
| Phone | 1-800-241-4002 |
| sapphireGCM@icumed.com | |
| Phone | 1-800-241-4002 |
| sapphireGCM@icumed.com | |
| Phone | 1-800-241-4002 |
| sapphireGCM@icumed.com | |
| Phone | 1-800-241-4002 |
| sapphireGCM@icumed.com |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290109150109 [Direct Marking] |
| GS1 | 17290109150106 [Primary] |
| GS1 | 27290109150103 [Package] Contains: 17290109150106 Package: cardboard box [8 Units] In Commercial Distribution |
| FRN | Pump, Infusion |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-01 |