Identity
- Trade Name
- Specimen Collection Bottle FDA UDI
- Generic Name
- Specimen container mailer, non-insulated FDA UDI
- Device Name
- 200ml FDA UDI
- Model / Reference
- U12A010110 FDA UDI
- Description
- 200ml FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06936881156649 FDA UDI
- FDA Product Code
- FMH FDA UDI
- GMDN Term
- Specimen container mailer, non-insulated FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.3250 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Specimen container mailer, non-insulated
Specimen Collection Bottle by Well Lead Medical Co., Ltd — 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
- Well Lead Medical Co., Ltd
Sources (1)
- FDA UDI 00b25d39-6167-497d-9610-2ca752800d46 33 fields · synced Jun 6, 2026