ManoScan FGS-8039
GUDID 07290101366973
Assy, ManoScan Cart
Covidien LP
Manometric gastrointestinal motility analysis system| Primary Device ID | 07290101366973 |
| NIH Device Record Key | bc3ce5af-7199-4b5e-b0fa-c56204a7c62d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ManoScan |
| Version Model Number | FGS-8039 |
| Catalog Number | FGS-8039 |
| Company DUNS | 058614483 |
| Company Name | Covidien LP |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | false |
| 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 |
Customer Support Contacts
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290101366973 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K151086
FDA Product Code
| FFX | SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2019-11-08 |
| Device Publish Date | 2017-06-27 |
On-Brand Devices [ManoScan]
| 07290110360368 | GIFD WS PC, 3050 Win 10 with SW |
| 07290110360344 | GIFD laptop, 5480 Win 10 with SW |
| 07290101366973 | Assy, ManoScan Cart |
| 07290101366188 | HRM/CLT WS, Dell 3020 W7 |
| 07290101366102 | CLT v3.0 software upgrade |
| 07290101365945 | v3.0 software kit upgrade |
| 07290101365921 | v3.0 software kit |
| 07290101365914 | Notebook, Dell E6440 Win 7 |
| 07290101365877 | Dell 3020 Win XP GT |
| 07290101365860 | Dell 3020 Win 7 |
| 07290101365679 | A550 Manometry Module |
| 07290101365600 | Balloon, ARM 150cc, 10-pack |
| 07290101365594 | Balloon, ARM 600cc, 10-pack |
| 07290101365587 | Balloon, ARM 400cc, 10-pack |
| 07290101365433 | ESOZ accessory kit,PWS |
| 07290101365426 | ESO accessory kit, PWS |
| 07290101365402 | PDU, holding plate & top case mount |
| 07290101364290 | V A400 Module |
| 07290101363958 | 4279GIV CART CAL CHAMBER RIGIDAR HDMVS |
| 07290101363736 | SSI Cal Chamber Mount |
| 07290101363729 | Non SSI Cal Chamber Mount 3DAR |
| 07290101363712 | Cal Chamber Mount MVS |
| 07290101363705 | Cal Chamber Mount 3DAR |
| 07290101363590 | 3D A300 Module, RFB |
| 07290101363583 | A120 Module |
| 07290101363545 | Z A200 Module, RFB |
| 07290101363521 | A120 Module |
| 07290101362685 | 3D A300 Module |
| 07290101362678 | Z A200 Module |
| 05704736001328 | SUM 8ch radial w/balloon, |
| 05704736001311 | 8ch Anorectal SUM 0,0.5 |
| 05704736001304 | 4 ch Anorectal Cat. Sil. w/Bal, |
| 05704736001298 | Single use Catheter 4 ch w/o central lum |
| 05704736001281 | 4ch 7.5mm sp Esophageal |
| 05704736001274 | 8ch Anorectal SinUse Man, |
| 05704736001267 | 8ch Vector Vol. SinUse Man |
| 05704736001250 | 4ch Anorectal SinUse Man.cath,0,1,2,3-ba |
| 05704736001243 | 8ch Esophageal Sinuse Ma, |
| 05704736001236 | 8ch Esophageal Sinuse Ma, |
| 05704736001229 | Esophageal SinUse Man. Cath.,0,5,10,15 c |
| 04260167483719 | MSS-4581-3D MANOSHIELD 3DAR - BOX 10 |
| 04260167483597 | ESO Catheter, RFG |
| 04260167482637 | ESO 3D Catheter |
| 04260167482545 | AR Catheter, Small |
| 04260167482538 | AR 3D Probe |
| 04260167482507 | ESO Z Catheter |
| 04260167482491 | ESO With Extended Tip |
| 04260167482262 | Assy, Retail Box of 20, ManoShield SD |
| 04260167482248 | Assy, Retail Box of 10, ManoShield AR |
| 04260167482200 | Assy, Retail Box of 20, ManoShield EG |
Trademark Results [ManoScan]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MANOSCAN 85684466 4301322 Live/Registered |
COVIDIEN LP 2012-07-23 |
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