Identity
- Trade Name
- AccuTag FDA UDI
- Generic Name
- Blood irradiation indicator FDA UDI
- Device Name
- 15Gy Min Blood Irradiation Indicator FDA UDI
- Model / Reference
- AT15 FDA UDI
- Description
- 15Gy Min Blood Irradiation Indicator FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07540151300107 FDA UDI
- FDA Product Code
- KSS FDA UDI
- GMDN Term
- Blood irradiation indicator FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.9050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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 irradiation indicator
AccuTag by Radtag Technologies Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Blood irradiation indicator.
- Reservoir Bag — Typenex Medical, LLC · Class I
- Reservoir Bag — Typenex Medical, LLC · Class I
- Rad Control — Typenex Medical, LLC · Class I
- Rad Control — Typenex Medical, LLC · Class I
- Rad Control — Typenex Medical, LLC · Class I
- Rad Control — Typenex Medical, LLC · Class I
- Rad Control — Typenex Medical, LLC · Class I
- Rad Control — Typenex Medical, 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
- Radtag Technologies Inc
Sources (1)
- FDA UDI 5c213d76-601e-419a-973f-622d84fc005c 33 fields · synced May 30, 2026