Eurotrol 250.003.002
GUDID 08718734960539
Assayed Quality control solution
Eurotrol B.V.
Total haemoglobin (totHb) IVD, control| Primary Device ID | 08718734960539 |
| NIH Device Record Key | 9130affe-54e3-49cf-8d3c-afe1a96ec42e |
| Commercial Distribution Discontinuation | 2016-08-27 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Eurotrol |
| Version Model Number | 250.003.002 |
| Catalog Number | 250.003.002 |
| Company DUNS | 412925992 |
| Company Name | Eurotrol B.V. |
| Device Count | 2 |
| 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 | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 9785983779 |
| officeUSA@eurotrol.com | |
| Phone | 9785983779 |
| officeUSA@eurotrol.com | |
| Phone | 9785983779 |
| officeUSA@eurotrol.com | |
| Phone | 9785983779 |
| officeUSA@eurotrol.com | |
| Phone | 9785983779 |
| officeUSA@eurotrol.com | |
| Phone | 9785983779 |
| officeUSA@eurotrol.com | |
| Phone | 9785983779 |
| officeUSA@eurotrol.com | |
| Phone | 9785983779 |
| officeUSA@eurotrol.com | |
| Phone | 9785983779 |
| officeUSA@eurotrol.com | |
| Phone | 9785983779 |
| officeUSA@eurotrol.com | |
| Phone | 9785983779 |
| officeUSA@eurotrol.com | |
| Phone | 9785983779 |
| officeUSA@eurotrol.com | |
| Phone | 9785983779 |
| officeUSA@eurotrol.com | |
| Phone | 9785983779 |
| officeUSA@eurotrol.com | |
| Phone | 9785983779 |
| officeUSA@eurotrol.com | |
| Phone | 9785983779 |
| officeUSA@eurotrol.com |
Operating and Storage Conditions
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08718734960539 [Primary] |
| GS1 | 08718734960546 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K964052
FDA Product Code
| GGM | Control, Hemoglobin |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2025-01-28 |
| Device Publish Date | 2016-08-26 |
On-Brand Devices [Eurotrol]
| 08718734960928 | Product is packaged in Eurotrol boxes, containing 5 ampules, one ampule of each level. It is a c |
| 08718734960904 | 179.003.010 |
| 08718734960881 | 179.002.010 |
| 08718734960867 | 179.001.010 |
| 08718734960539 | Assayed Quality control solution |
| 08718734960515 | Assayed Quality control solution |
| 08718734960492 | Assayed Quality control solution |
Trademark Results [Eurotrol]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EUROTROL 79341935 not registered Live/Pending |
Eurotrol B.V. 2022-04-25 |
 EUROTROL 77283386 3448423 Live/Registered |
Eurotrol B.V. 2007-09-19 |
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