Identity
- Trade Name
- ASTOTUBE® FDA UDI
- Generic Name
- Intravenous administration tubing extension set FDA UDI
- Device Name
- DEHP-free FDA UDI
- Model / Reference
- M77460002 FDA UDI
- Description
- DEHP-free FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260114141440 FDA UDI
- 510(k) Number
- K991160 FDA UDI
- FDA Product Code
- BSB FDA UDI
- GMDN Term
- Intravenous administration tubing extension set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9205 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
Yes
FDA UDI
Category: Intravenous administration tubing extension set
Astotube® by Stihler Electronic GmbH — Class II — MDD, MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K991160 also covers:
- ASTOLINE — Stihler Electronic GmbH
- ASTOLINE — Stihler Electronic GmbH
- ASTOTHERM® PLUS — Stihler Electronic GmbH
- ASTOTHERM® PLUS — Stihler Electronic GmbH
- ASTOTHERM® PLUS — Stihler Electronic GmbH
- ASTOTHERM® PLUS — Stihler Electronic GmbH
- ASTOTHERM® PLUS — Stihler Electronic GmbH
- ASTOTHERM® PLUS — Stihler Electronic GmbH
- ASTOTHERM® PLUS — Stihler Electronic GmbH
- ASTOTHERM® PLUS — Stihler Electronic GmbH
- ASTOTHERM® PLUS — Stihler Electronic GmbH
- ASTOTHERM® PLUS — Stihler Electronic GmbH
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Stihler Electronic GmbH
Sources (2)
- FDA UDI 78b5d31a-ddb6-4143-9d55-952c74923dbb 35 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 18, 2026