Identity
- Trade Name
- PettyPip FDA UDI
- Generic Name
- Biological fluid specimen capillary collector IVD FDA UDI
- Device Name
- The pettyPip is a device for collecting 10 uL of whole blood and injecting it into the IVD device, such as POC or NPT devices. This device is composed of two parts; a Tip and a Plunger. The hole at the top end of the plunger provides sample collection through capillary action. FDA UDI
- Model / Reference
- PettyPip FDA UDI
- Description
- The pettyPip is a device for collecting 10 uL of whole blood and injecting it into the IVD device, such as POC or NPT devices. This device is composed of two parts; a Tip and a Plunger. The hole at the top end of the plunger provides sample collection through capillary action. FDA UDI
Identifiers
- Catalog Number
- CT10300E FDA UDI
- Primary DI / UDI-DI
- 08809408863505 FDA UDI
- FDA Product Code
- GIO FDA UDI
- GMDN Term
- Biological fluid specimen capillary collector IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.6150 FDA UDI
- Commercial Distribution
- 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
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Biological fluid specimen capillary collector IVD
PettyPip by Sugentech Inc._Osong Branch — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Biological fluid specimen capillary collector IVD.
- Medline — MEDLINE INDUSTRIES, INC. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sugentech Inc._Osong Branch
Sources (2)
- FDA UDI 6d98ad19-7760-47ac-bf56-a333103a2089 36 fields · synced Jun 8, 2026
- EUDAMED 1 fields · synced Jun 3, 2026