| Primary Device ID | 04260167484037 |
| NIH Device Record Key | e0e806de-2928-4178-a22d-3d32850c7320 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Versaflex |
| Version Model Number | 957980 |
| Catalog Number | 957980 |
| 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 | 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 |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
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| 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 |
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| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
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| 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 | |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile; |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile; |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Fragile |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04260167484037 [Primary] |
| FFT | Electrode, pH, stomach |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-11-08 |
| Device Publish Date | 2018-08-29 |
| 07290101365167 | catheter, LPR starter kit |
| 04260167483436 | Disposable pH / Impedance Catheter, Dual pH Sensor, 25cm, 8 Impedance Rings, LPR ZNID25+8R |
| 04260167483429 | Disposable pH / Impedance Catheter, Dual pH Sensor, 22cm, 8 Impedance Rings, LPR ZNID22+8R |
| 04260167483412 | Disposable pH / Impedance Catheter, Dual pH Sensor, 19cm, 8 Impedance Rings, LPR ZNID19+8R |
| 04260167483405 | Disposable pH / Impedance Catheter, Dual pH Sensor, 15cm, 8 Impedance Rings, LPR ZNID15+8R |
| 04260167483399 | Disposable pH / Impedance Catheter, Dual pH Sensor, 12cm, 8 Impedance Rings, LPR ZNID12+8R |
| 04260167481500 | Disposable pH Catheter, Dual Sensor, 15cm, LES Locator, VIID15 |
| 04260167484037 | Disposable pH Catheter, Single Sensor, LES Locator, VIIS |
| 04260167481463 | Disposable pH Catheter, Triple Sensor, XX and XXcm, VNITXX |
| 04260167481449 | Disposable pH Catheter, Dual Sensor, 7.5cm, VNID7.5 |
| 04260167481432 | Disposable pH Catheter, Dual Sensor, 21cm, VNID21 |
| 04260167481425 | Disposable pH Catheter, Dual Sensor, 18cm, VNID18 |
| 04260167481418 | Disposable pH Catheter, Dual Sensor, 15cm, VNID15 |
| 04260167481401 | Disposable pH Catheter, Dual Sensor, 10cm, VNID10 |
| 04260167481395 | Disposable pH Catheter, Dual Sensor, 5cm, VNID05 |
| 04260167481388 | Disposable pH Catheter, Single Sensor, VNIS |
| 04260167481364 | Disposable pH Catheter, Dual Sensor, 15cm, Large Diameter, VNID15/LD |
| 04260167481357 | Disposable pH Catheter, Dual Sensor, 10cm, Large Diameter, VNID10/LD |
| 04260167481340 | Disposable pH Catheter, Dual Sensor, 5cm, Large Diameter, VNID05/LD |
| 04260167481333 | Disposable pH Catheter, Single Sensor, Large Diameter, VNIS/LD |
| 04260167481326 | Disposable pH Catheter, Dual Sensor, 21cm, ENT, VNID21+ENT |
| 04260167481319 | Disposable pH Catheter, Dual Sensor, 18cm, ENT, VNID18+ENT |
| 04260167481302 | Disposable pH Catheter, Dual Sensor, 15cm, ENT, VNID15+ENT |
| 04260167481296 | Disposable pH Catheter, Dual Sensor, 10cm, ENT, VNID10+ENT |
| 04260167483559 | Disposable pH Catheter, Dual Sensor, 18cm, ENT, Large Diameter, VNID18/LD+ENT |
| 04260167483535 | Disposable pH Catheter, Bifurcated Probe 1: Single, Probe 2: Dual, 10cm, VNIS+UD10 |
| 04260167481289 | Disposable pH Catheter, Bifurcated Probe 1: Single, Probe 2: Single, VNIS+US |
| 04260167483566 | Disposable pH / Impedance Catheter, Single pH Sensor, 8 Impedance Rings, ZNIS+8R |
| 04260167481173 | Disposable pH / Impedance Catheter, Single pH Sensor, 8 Impedance Rings, ZNIS+8R |
| 04260167482330 | Disposable pH / Impedance Catheter, Single pH Sensor, 7 Impedance Rings, Infant, ZNIS+7R1.5 |
| 04260167482323 | Disposable pH / Impedance Catheter, Single pH Sensor, 7 Impedance Rings, Pediatric, ZNIS+7R2.0 |
| 04260167482316 | Disposable pH / Impedence Catheter, Dual pH Sensor, 15cm, 8 Impedance Rings, ZNID15+8R |
| 04260167483481 | Disposable pH Catheter, Dual Sensor, 21cm, LES Locator, VIID21 |
| 04260167483276 | Disposable pH Catheter, Single Sensor, VNIS |
| 04260167483184 | Disposable pH / Impedance Catheter, Single pH Sensor, 8 Impedance Rings, ZNIS+8R |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() VERSAFLEX 98565346 not registered Live/Pending |
Symmons Industries, Inc. 2024-05-23 |
![]() VERSAFLEX 98270163 not registered Live/Pending |
Chubby Gorilla, Inc. 2023-11-14 |
![]() VERSAFLEX 98108746 not registered Live/Pending |
Versatrim, LLC 2023-07-31 |
![]() VERSAFLEX 97496862 not registered Live/Pending |
Urethane Sciences, LLC 2022-07-11 |
![]() VERSAFLEX 97163830 not registered Live/Pending |
mk North America, Inc. 2021-12-09 |
![]() VERSAFLEX 90271746 not registered Live/Pending |
Medline Industries, Inc. 2020-10-22 |
![]() VERSAFLEX 88910403 not registered Live/Pending |
Berry Global, Inc. 2020-05-11 |
![]() VERSAFLEX 88627125 not registered Live/Pending |
Plews, Inc. 2019-09-23 |
![]() VERSAFLEX 88521670 not registered Live/Pending |
mk North America, Inc. 2019-07-18 |
![]() VERSAFLEX 88497551 not registered Live/Pending |
VERSAFLEX, INC. 2019-07-02 |
![]() VERSAFLEX 88249805 not registered Live/Pending |
Unisafe, Inc. 2019-01-04 |
![]() VERSAFLEX 87283183 5250496 Live/Registered |
Jamison Door Company 2016-12-28 |