Identity
- Trade Name
- Genesis Tube Stripper FDA UDI
- Generic Name
- Blood tube stripper FDA UDI
- Device Name
- The Tube Stripper is a “plier-like” tool used to strip/expel undiluted residual blood, in the PVC tubing segment, back into the blood component bag. The Tube Stripper operates on the principle of using two rolling wheels to squeeze fluid forward. The operator manually places the PVC tubing segment between the two roller wheels, grips the clamp body, and slides the Tube Stripper forward along the PVC tubing segment. As the segment is compressed between the two roller wheels, the residual blood within the PVC tubing segment flows forward until it completely drains into the blood component bag. When used in blood/blood component processing applications, the Tube Stripper facilitates manual mixing with anticoagulant and red cells. The Tube Stripper has no intended medical purpose and is not intended for in vitro use in blood banking. FDA UDI
- Model / Reference
- HS-002 FDA UDI
- Description
- The Tube Stripper is a “plier-like” tool used to strip/expel undiluted residual blood, in the PVC tubing segment, back into the blood component bag. The Tube Stripper operates on the principle of using two rolling wheels to squeeze fluid forward. The operator manually places the PVC tubing segment between the two roller wheels, grips the clamp body, and slides the Tube Stripper forward along the PVC tubing segment. As the segment is compressed between the two roller wheels, the residual blood within the PVC tubing segment flows forward until it completely drains into the blood component bag. When used in blood/blood component processing applications, the Tube Stripper facilitates manual mixing with anticoagulant and red cells. The Tube Stripper has no intended medical purpose and is not intended for in vitro use in blood banking. FDA UDI
Identifiers
- Catalog Number
- 4A-HS-002 FDA UDI
- Primary DI / UDI-DI
- 00866305000288 FDA UDI
- FDA Product Code
- KSQ FDA UDI
- GMDN Term
- Blood tube stripper FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.9195 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Blood tube stripper
Genesis Tube Stripper by Genesisbps Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Genesisbps Llc
Sources (1)
- FDA UDI b7055494-6d57-41d3-b4b3-aad38d49e95a 34 fields · synced May 30, 2026