Primary Device ID | 00853360007109 |
NIH Device Record Key | 00863336-c806-486c-b5ac-9bde7b352533 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | The Völkner® Turning System |
Version Model Number | EUROPA I Mattress Overlay 84" Special Production |
Company DUNS | 183085083 |
Company Name | JAMES CONSOLIDATED, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | MR Unsafe |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | false |
Manufacturing Date | true |
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 | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00853360007109 [Primary] |
FNM | Mattress, Air Flotation, Alternating Pressure |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2019-05-01 |
Device Publish Date | 2016-11-18 |
00853360007147 | PANDA III 54" Bariatric Mattress Replacement 84" |
00853360007130 | PANDA III 48" Bariatric Mattress Replacement 84" |
00853360007123 | MARK II Mattress Replacement 84" Special Producti |
00853360007116 | MARK I Mattress Overlay 84" Special Production |
00853360007109 | EUROPA I Mattress Overlay 84" Special Production |
00853360007093 | BETA II Mattress Replacement 84" Special Productio |
00853360007086 | BETA I Mattress Overlay 84" Special Production |
00853360007079 | PANDA III 54" Bariatric Mattress Replacement |
00853360007062 | PANDA III 48" Bariatric Mattress Replacement |
00853360007048 | EUROPA I Mattress Overlay |
00853360007031 | MARK II Mattress Replacement |
00853360007024 | MARK I Mattress Overlay |
00853360007017 | BETA II Mattress Replacement |
00853360007000 | BETA I Mattress Overlay |