QuikClot 0487
GUDID 00841495104879
QuikClot Z-Fold Hemostatic Dressing
Z-MEDICA, LLC
Inorganic haemostatic agent, sterile| Primary Device ID | 00841495104879 |
| NIH Device Record Key | 3a479816-2949-4f06-a6ef-26867b500c45 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | QuikClot |
| Version Model Number | 0487 |
| Catalog Number | 0487 |
| Company DUNS | 079190073 |
| Company Name | Z-MEDICA, 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 | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841495104879 [Primary] |
| GS1 | 30841495104870 [Package] Package: CARTON [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K123387
FDA Product Code
| FRO | Dressing, Wound, Drug |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-09-27 |
On-Brand Devices [QuikClot]
| 00841495140303 | QuikClot Control+ Hemostatic Dressing 12" x 12" 3-ply TraumaPad |
| 00841495140105 | QuikClot Control+ Hemostatic Dressing 8" x 8" 2-ply TraumaPad |
| 50841495106335 | QuikClot Roll Hemostatic Dressing,CE,Multi-lg,10x |
| 50841495106328 | QuikClot Z-Fold Hemostatic Dressing,Mult-lang,CE,10x |
| 50841495103037 | QuikClot TraumaPad, CE,Multi-language, 10x |
| 50841495103020 | QuikClot Hemostatic Dressing 2x2 ,CE,Multi-lang10x |
| 50841495103013 | QuikClot Hemostatic Dressing 4x4 ,CE,Multi-lang10x |
| 00841495140204 | QuikClot Control+ Hemostatic Dressing 3" x 2 yard Z-fold |
| 00841495140006 | QuikClot Control+ Hemostatic Dressing 5" x 5" 4-ply |
| 00841495104879 | QuikClot Z-Fold Hemostatic Dressing |
| 00841495104756 | QuikClot EMS Rolled Gauze |
| 00841495104732 | QuikClot EMS 4x4 Dressing |
| 00841495104671 | QuikClot Interventional, n/Clamshell,n/Tegaderm,Multi-Lang 10x |
| 00841495104619 | QuikClot Roll Hemostatic Dressing |
| 00841495104602 | QuikClot TraumaPad |
| 50841495104591 | QuikClot Hemostatic Dressing, 4x4 |
| 00841495104589 | QuikClot Hemostatic Dressing, 2x2 |
| 00841495103742 | QuikClot Radial |
| 00841495103506 | QuikClot Combat Gauze LE |
| 00841495103452 | QuikClot Combat Gauze XL |
| 50841495102894 | QuikClot Combat Gauze,CE,German,1x |
| 00841495102103 | QuikClot Combat Gauze TraumaPad |
| 00841495101885 | QuikClot Interventional Pre-Slit w/ Tegaderm |
| 00841495101830 | QuikClot Interventional w/ Tegaderm |
| 00841495102615 | BTK, Combat Gauze LE |
| 00841495106224 | QuikClot Bleeding Control Bag, OTC,SOFTT-W |
| 00841495106217 | QuikClot Bleeding Control Bag, OTC, CAT |
| 50841495105727 | QuikClot Bleeding Control Dressing 3 IN x 4 FT |
| 50841495105383 | QuikClot Bleeding Control Dressing 3"x4yd,1x |
| 30841495106362 | QuikClot EMS 4x4 Dressing w/X-ray |
| 00841495106132 | QuikClot Bleeding Control Kit, Stanford, OTC, CAT |
| 00841495106125 | QuikClot Bleeding Control Kit, OTC, SOFTT-W |
| 00841495106118 | QuikClot Bleeding Control Kit, OTC, CAT |
| 00841495105838 | BTK+, CG LE, H&H,Sof-T,Large |
| 00841495105494 | QuikClot Bleeding Control Bag, SOFTTW, NYPD |
| 00841495105395 | BCK, QuikClot Bleeding Control Kit, CAT, Pro |
| 00841495105265 | BTK+, CG LE, H&H, CAT |
| 00841495104992 | BTK,QC Combat Gauze,SWAT-T |
| 00841495102004 | QuikClot Combat Gauze |
| 00841495105487 | QuikClot Bleeding Control Bag,SOFTT-W, PRO |
| 00841495105470 | QuikClot Bleeding Control Bag,CAT,PRO |
| 00841495105418 | QuikClot Bleeding Control Kit, CG LE, H&H, CAT, UPMC |
| 00841495105401 | QuikClot Bleeding Control Kit,SOFTT-W, Pro |
| 00841495105340 | BTK+, CG LE, H&H, Orange SOFTT-W,Large |
| 30841495140502 | QuikClot Control+ Hemostatic Dressing 5" x 5" 4-ply |
| 50841495120102 | QC Combat Gauze, Japanese,1x |
| 50841495105109 | QC Combat Gauze, Spanish,1x |
Trademark Results [QuikClot]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 QUIKCLOT 87366569 5333782 Live/Registered |
Z-MEDICA, LLC 2017-03-10 |
 QUIKCLOT 87366551 5333781 Live/Registered |
Z-MEDICA, LLC 2017-03-10 |
 QUIKCLOT 86550844 4930601 Live/Registered |
Z-MEDICA, LLC 2015-03-02 |
 QUIKCLOT 76388756 2798757 Live/Registered |
Z-MEDICA, LLC 2002-03-27 |
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