Duns Number:004324596
Device Description: UMF Medical 8678 Phlebotomy Chair w/ Power Hi-Lo & Power Backrest, ADA Height, two-functio UMF Medical 8678 Phlebotomy Chair w/ Power Hi-Lo & Power Backrest, ADA Height, two-function hand control with OneTouch Patient Positioning® System, self-positioning armrests and self-positioning leg rest. Reclines to 30° from horizontal position. 375lb (170.1kg) patient weight capacity. Seamless upholstery. Available in 8 Colors
Catalog Number
-
Brand Name
UMF Medical
Version/Model Number
8678
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
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Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
INQ
Product Code Name
Table, Powered
Public Device Record Key
e9ff8e17-f92a-47fe-adba-ab8892041460
Public Version Date
October 16, 2020
Public Version Number
2
DI Record Publish Date
September 24, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 155 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |