FDA UDI In Commercial Distribution 🇺🇸 United States

Genesis Tube Stripper

DI: 00866305000288 · Model: HS-002 · GENESIS BPS LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Genesis Tube Stripper
Primary DI
00866305000288
Version / Model
HS-002
Catalog Number
4A-HS-002
Company Name
GENESIS BPS LLC
Labeler DUNS
141091095
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-01-31
Public Version
1
Public Version Date
2025-02-10
Public Version Status
New
Public Device Record Key
b7055494-6d57-41d3-b4b3-aad38d49e95a

Device 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.

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
KSQ Device, Blood Mixing And Blood Weighing

GMDN Terms

Code Name
37851 Blood tube stripper

Identifiers

Type ID
Primary 00866305000288