Identity
- Trade Name
- Medichoice FDA UDI
- Generic Name
- Mechanical pipette FDA UDI
- Device Name
- Decanter Bag For Aseptic Transfer Of Fluids From Flexible Containers Acrylonitrile-Butadiene-Styrene Plastic Sterile Not Made With Natural Rubber Latex MediChoice FDA UDI
- Model / Reference
- BD10102 FDA UDI
- Description
- Decanter Bag For Aseptic Transfer Of Fluids From Flexible Containers Acrylonitrile-Butadiene-Styrene Plastic Sterile Not Made With Natural Rubber Latex MediChoice FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10885632107634 FDA UDI
- 510(k) Number
- K852777 FDA UDI
- FDA Product Code
- KPE FDA UDI
- GMDN Term
- Mechanical pipette FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5025 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Mechanical pipette
Medichoice by Owens & Minor Distribution, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Mechanical pipette.
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- Wallace — ICU MEDICAL, INC. · Class II
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- LabChoice Mechanical Pipette, Single Channel, Adjustable Volume 0.5 - 5 ML — Dynarex Corp. · Class I
- Sunbiotec — Hubei Huamei Sunlight Biotechnologies Co., Ltd · Class II
- Wallace — ICU MEDICAL, INC. · Class II
- SLM — Sunlight Medical, Inc. · Class II
Cleared under the same submission
K852777 also covers:
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Owens & Minor Distribution, Inc.
Sources (1)
- FDA UDI 244cd977-b6ca-4f6f-83b8-f98179d69aeb 34 fields · synced May 30, 2026