QT Micro TM6100
GUDID 00854989006108
TM6100, 1 each, 0.22µ Contamination tester, female luer lock inlet, male luer slip outlet. TM6100, case of 10, includes 5cc syringe of TSB Media. TM6101, case of 10, includes 5cc syringe of FTM Media
Q. I. MEDICAL, INC.
Fluid transfer set, general-purpose| Primary Device ID | 00854989006108 |
| NIH Device Record Key | bf970ee9-cddb-4c77-83dc-8148b51e8315 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | QT Micro |
| Version Model Number | Contamination Tester, luer slip outlet |
| Catalog Number | TM6100 |
| Company DUNS | 800082950 |
| Company Name | Q. I. MEDICAL, INC. |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00854989006108 [Primary] |
| GS1 | 00854989006115 [Package] Package: Box [10 Units] In Commercial Distribution |
| GS1 | 00854989006122 [Package] Package: Box [10 Units] In Commercial Distribution |
| GS1 | 10854989006105 [Package] Package: Bulk case [200 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K950305
FDA Product Code
| LHI | Set, I.V. Fluid Transfer |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00854989006108]
Ethylene Oxide
[00854989006108]
Ethylene Oxide
[00854989006108]
Ethylene Oxide
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Ethylene Oxide
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[00854989006108]
Ethylene Oxide
[00854989006108]
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Ethylene Oxide
[00854989006108]
Ethylene Oxide
[00854989006108]
Ethylene Oxide
[00854989006108]
Ethylene Oxide
[00854989006108]
Ethylene Oxide
[00854989006108]
Ethylene Oxide
[00854989006108]
Ethylene Oxide
[00854989006108]
Ethylene Oxide
[00854989006108]
Ethylene Oxide
[00854989006108]
Ethylene Oxide
[00854989006108]
Ethylene Oxide
[00854989006108]
Ethylene Oxide
[00854989006108]
Ethylene Oxide
[00854989006108]
Ethylene Oxide
[00854989006108]
Ethylene Oxide
[00854989006108]
Ethylene Oxide
[00854989006108]
Ethylene Oxide
[00854989006108]
Ethylene Oxide
[00854989006108]
Ethylene Oxide
[00854989006108]
Ethylene Oxide
[00854989006108]
Ethylene Oxide
[00854989006108]
Ethylene Oxide
[00854989006108]
Ethylene Oxide
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Ethylene Oxide
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Ethylene Oxide
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-03-10 |
On-Brand Devices [QT Micro]
| 00854989006108 | TM6100, 1 each, 0.22µ Contamination tester, female luer lock inlet, male luer slip outlet. TM61 |
| 00854989006078 | TM6000,1 each, 0.22µ Contamination tester, female luer lock inlet, female luer lock outlet. TM |
Trademark Results [QT Micro]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 QT MICRO 86737056 5052695 Live/Registered |
Q.I. Medical, Inc. 2015-08-25 |
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