| Primary Device ID | 10850144008038 |
| NIH Device Record Key | 46ed03c9-d1d7-44ac-a01d-0a973c85dbd7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Getinge Pack Self-Seal Pouch |
| Version Model Number | GUKP1530 |
| Catalog Number | 61301606726 |
| Company DUNS | 565751992 |
| Company Name | PMS TIBBI CIHAZLAR TEKNOLOJISI SANAYI VE TICARET ANONIM SIRKETI |
| Device Count | 200 |
| 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 | true |
| 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 | true |
| Phone | 4196935300 |
| rdean@lexamed.net |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850144008031 [Primary] |
| GS1 | 10850144008038 [Package] Contains: 00850144008031 Package: case [14 Units] In Commercial Distribution |
| GS1 | 20850144008035 [Unit of Use] |
| JOJ | Indicator, Physical/Chemical Sterilization Process |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-11-08 |
| Device Publish Date | 2017-08-29 |
| 00850144008079 | Self-Seal Pouch 33cm x 46cm |
| 00850144008062 | Self-Seal Pouch 30cm x 45cm |
| 10850144008052 | Self-Seal Pouch 25cm x 38cm |
| 00850144008048 | Self-Seal Pouch 20cm x 41cm |
| 10850144008038 | Self-Seal Pouch 15cm x 30cm |
| 10850144008021 | Self-Seal Pouch 13cm x 38cm |
| 10850144008014 | Self-Seal Pouch 10cm x 28cm |
| 10850144008007 | Self-Seal Pouch 9cm x 25cm |