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Adt/Med BiteBlk CO2 Line w/O2 Conn STerm
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 989803204451
Identity
- Trade Name
- Adt/Med BiteBlk CO2 Line w/O2 Conn STerm EUDAMEDMicrostream Advance Adult-Intermediate Bite Block CO2 Filter Line FDA UDI
- Generic Name
- Nasal oxygen cannula, carbon-dioxide-sampling FDA UDI
- Device Name
- Microstream Advanced Capnography Lines EUDAMEDMicrostream Advance Adult-Intermediate Bite Block CO2 Filter Line FDA UDI
- Model / Reference
- 989803204451 EUDAMEDAdt/Med BiteBlk CO2 Line w/O2 Conn STerm FDA UDI
- Description
- Microstream Advance Adult-Intermediate Bite Block CO2 Filter Line FDA UDI
Identifiers
- Catalog Number
- 989803204451 FDA UDI
- Primary DI / UDI-DI
- 20884838093748 EUDAMEDFDA UDI
- Basic UDI-DI
- B-20884838093748 EUDAMED
- 510(k) Number
- K093388 FDA UDI
- FDA Product Code
- CCK FDA UDI
- EMDN Code
- Z1203020202 TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS EUDAMED
- GMDN Term
- Nasal oxygen cannula, carbon-dioxide-sampling FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.1400 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Adt/Med BiteBlk CO2 Line w/O2 Conn STerm by Philips Medical Systems — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-20884838093748 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Philips Medical Systems
- EUDAMED SRN
- US-MF-000002321
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (2)
- EUDAMED 15c45e5c-017c-4d72-aacd-b471d93ede79 61 fields · synced Jul 25, 2026
- FDA UDI 2357c21d-b508-4992-a51a-236bcf1d4a6b 37 fields · synced May 30, 2026