Identity
- Trade Name
- pts collect™ Capillary Tubes FDA UDI
- Generic Name
- Capillary blood collection tube IVD, no additive FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 2864 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- 2864 FDA UDI
- Primary DI / UDI-DI
- 00381932864015 FDA UDI
- FDA Product Code
- GIO FDA UDI
- GMDN Term
- Capillary blood collection tube IVD, no additive FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.6150 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
pts collect™ Capillary Tubes by Polymer Technology Systems — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Polymer Technology Systems
Sources (1)
- FDA UDI 4d0d50ae-13fe-4982-bece-3aa754d7aeab 36 fields · synced Jun 1, 2026