Duns Number:835772872
Device Description: The tubes are a combination of a short glass capillary pipette that is physically combined The tubes are a combination of a short glass capillary pipette that is physically combined with a plastic pipette that is capable of dispensing a given volume of blood from the capillary tube to a test strip. The glass capillary draws blood from a finger stick site using capillary force. Two small vents in the plastic bulb allow for capillary action. After drawing up of the blood into the glass tube, the two small vents in the plastic tube are then covered with two fingers and the bulb is squeezed to dispense the blood. The PTS Collect capillary tubes are single-use, disposable devices.
Catalog Number
2134
Brand Name
pts collect™ Capillary Tubes
Version/Model Number
2134
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"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GIO
Product Code Name
TUBE, COLLECTION, CAPILLARY BLOOD
Public Device Record Key
8953721f-3ce7-4277-b5d1-c320ce474135
Public Version Date
April 13, 2022
Public Version Number
4
DI Record Publish Date
September 18, 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 | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |