Digitrapper 800004
GUDID 07290101362906
recorder, pH-Z
Given Imaging, Inc.
Gastric pH ambulatory recorder Gastric pH ambulatory recorder Gastric pH ambulatory recorder Gastric pH ambulatory recorder Gastric pH ambulatory recorder Gastric pH ambulatory recorder Gastric pH ambulatory recorder Gastric pH ambulatory recorder Gastric pH ambulatory recorder Gastric pH ambulatory recorder Gastric pH ambulatory recorder Gastric pH ambulatory recorder Gastric pH ambulatory recorder Gastric pH ambulatory recorder| Primary Device ID | 07290101362906 |
| NIH Device Record Key | cf18a805-6919-4b97-93d3-dbd048081acf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Digitrapper |
| Version Model Number | 800004 |
| Catalog Number | 800004 |
| Company DUNS | 090073722 |
| Company Name | Given Imaging, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| OTC Over-The-Counter | true |
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 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290101362906 [Primary] |
FDA Product Code
| FFT | Electrode, pH, stomach |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-11-08 |
| Device Publish Date | 2018-08-29 |
Devices Manufactured by Given Imaging, Inc.
| 07290110361068 - GIFD | 2020-01-17 PillCam sensor belt, DR3 C2 SBC |
| 04260167480954 - ManoScan | 2019-11-08 AR 3D Probe |
| 04260167480961 - ManoScan | 2019-11-08 ESO Catheter, SD Regular |
| 04260167482422 - ManoScan | 2019-11-08 ESO 3D Catheter |
| 04260167482439 - ManoScan | 2019-11-08 ESO With Extended Tip |
| 04260167482446 - ManoScan | 2019-11-08 ESO Z Catheter |
| 04260167482453 - ManoScan | 2019-11-08 ESO Catheter, SD Small |
| 04260167482460 - ManoScan | 2019-11-08 AR Catheter, Small |
Trademark Results [Digitrapper]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DIGITRAPPER 78642300 3103702 Live/Registered |
COVIDIEN LP 2005-06-02 |
 DIGITRAPPER 73566824 1397504 Dead/Cancelled |
SYNECTICS MEDICAL AB 1985-11-04 |
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