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PRAS Anaerobic Transport Medium Surgery Pk (ATM-SP)
EUDAMEDFDA UDIClass A (EU MDR)
Ref AS-914
Identity
- Trade Name
- PRAS Anaerobic Transport Medium Surgery Pk (ATM-SP) EUDAMEDPRAS Anaerobic Transport Medium - Surgery Pack (ATM-SP) FDA UDI
- Generic Name
- Anaerobic transport medium IVD FDA UDI
- Device Name
- Anaerobic Culture Media EUDAMEDAS-914 Anaerobic Transport Medium - Surgery Pack (ATM-SP) is a mineral salt based semi-solid media with reducing agents. Designed as a holding medium to maintain the viability of microorganisms, both anaerobic and aerobic, through collection, transportation, and shipment of clinical specimens. Individually packaged and sterilized for use in surgical setting. Pre-reduced anaerobically sterilized (PRAS). 6 mL fill volume. 16 x 100 mm hungate-capped tube. Transparent colorless semi-solid medium. 10 tubes per pack. FDA UDI
- Model / Reference
- AS-914 EUDAMEDFDA UDI
- Description
- AS-914 Anaerobic Transport Medium - Surgery Pack (ATM-SP) is a mineral salt based semi-solid media with reducing agents. Designed as a holding medium to maintain the viability of microorganisms, both anaerobic and aerobic, through collection, transportation, and shipment of clinical specimens. Individually packaged and sterilized for use in surgical setting. Pre-reduced anaerobically sterilized (PRAS). 6 mL fill volume. 16 x 100 mm hungate-capped tube. Transparent colorless semi-solid medium. 10 tubes per pack. FDA UDI
Identifiers
- Catalog Number
- AS-914 FDA UDI
- Primary DI / UDI-DI
- 00810048901258 EUDAMEDFDA UDI
- Basic UDI-DI
- 081004890ANAEROBEDT EUDAMED
- Unit of Use DI
- 00810048902408 EUDAMED
- FDA Product Code
- JSL FDA UDI
- EMDN Code
- W0104010203 TRANSPORT MEDIA EUDAMED
- GMDN Term
- Anaerobic transport medium IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 866.2390 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
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
PRAS Anaerobic Transport Medium Surgery Pk (ATM-SP) by Anaerobe Systems — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 081004890ANAEROBEDT | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Anaerobe Systems
- EUDAMED SRN
- US-MF-000040030
- Authorised Representative
- Casus Europe B.V. NL-AR-000037688
Sources (2)
- EUDAMED 9eb13b8f-59ff-468f-a597-347f340649f4 61 fields · synced Jul 12, 2026
- FDA UDI b30dd292-aad3-48cc-9022-f20e9b65eba1 36 fields · synced May 30, 2026