Identity
- Trade Name
- Corning FDA UDI
- Generic Name
- Blood/tissue storage/culture container FDA UDI
- Device Name
- Corning® 850cm² Polystyrene Roller Bottle with Easy Grip Cap, Sterile 22/Bag, 44/Case FDA UDI
- Model / Reference
- 431321 FDA UDI
- Description
- Corning® 850cm² Polystyrene Roller Bottle with Easy Grip Cap, Sterile 22/Bag, 44/Case FDA UDI
Identifiers
- Catalog Number
- 431321 FDA UDI
- Primary DI / UDI-DI
- H1084313211 FDA UDI
- FDA Product Code
- KJC FDA UDI
- GMDN Term
- Blood/tissue storage/culture container FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.2240 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
No
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
Category: Blood/tissue storage/culture container
Corning by Corning Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Blood/tissue storage/culture container.
- TERUFLEX TRANSFER BAG — Terumo Corp. · Class II
- Evolve — OriGen Biomedical, Inc. · Class I
- TC Flask T175, Stand., Vent. Cap — Sarstedt Aktiengesellschaft & Co.KG · Class I
- Aero-Med — AERO-MED LLC · Class I
- TC Flask T75, Suspension — Sarstedt Aktiengesellschaft & Co.KG · Class I
- Acrodose PLus System — HAEMONETICS CORPORATION · Class II
- TC Flask T75, Standard — Sarstedt Aktiengesellschaft & Co.KG · Class I
- Aero-Med — AERO-MED LLC · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Corning Incorporated
Sources (1)
- FDA UDI c2286cc6-b102-4140-884f-b5196c62c1bb 35 fields · synced May 31, 2026