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Wellead OXYGEN TUBING
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref R01C01451XModel Oxygen TubingRef R01C01211FModel Oxygen Tubing(Non-Sterile)Ref R01C01301FRef R01C01501XRef R01C01501FRef R01C01211X
Identity
- Trade Name
- Welllead Oxygen Tubing EUDAMEDWellead OXYGEN TUBING FDA UDI
- Generic Name
- Oxygen administration tubing FDA UDI
- Device Name
- Oxygen Tubing EUDAMED14ft(4.27m)STERILE FDA UDI50ft(15.24m)NON STERILE FDA UDI10ft(3.05m)NON STERILE FDA UDI7ft(2.13m)NON STERILE FDA UDI14ft(4.27m)NON STERILE FDA UDI
- Model / Reference
- R01C01501F EUDAMEDFDA UDIR01C01301F EUDAMEDFDA UDIR01C01211F EUDAMEDFDA UDIOxygen Tubing EUDAMEDR01C01451X EUDAMEDOxygen Tubing(Non-Sterile) EUDAMEDR01C01501X EUDAMEDR01C01211X EUDAMEDR01C01451Y FDA UDIR01C01451F FDA UDI
- Description
- 14ft(4.27m)STERILE FDA UDI50ft(15.24m)NON STERILE FDA UDI10ft(3.05m)NON STERILE FDA UDI7ft(2.13m)NON STERILE FDA UDI14ft(4.27m)NON STERILE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944932771321 EUDAMEDFDA UDI06944932771086 EUDAMEDFDA UDI06944932770966 EUDAMEDFDA UDI06944932771208 EUDAMEDFDA UDI06944932771215 EUDAMED06944932771338 EUDAMED06944932770973 EUDAMED06944932771222 FDA UDI
- Basic UDI-DI
- 69449327FR01C01K7 EUDAMED69449327FR01C00K5 EUDAMED
- FDA Product Code
- BZO FDA UDI
- EMDN Code
- R03010204 OXYGEN ADMINISTRATION TUBINGS EUDAMED
- GMDN Term
- Oxygen administration tubing FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5975 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDIEUDAMED
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
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: Oxygen administration tubing
Wellead OXYGEN TUBING by Well Lead Medical Co., Ltd — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| 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 (12)
- FDA UDI 7c5adab4-b722-40cf-8ddb-55d23f1ce1af 33 fields · synced Oct 6, 2026
- FDA UDI 828ea888-0a74-4c8c-a533-259fd939ee49 33 fields · synced May 30, 2026
- FDA UDI 68b4eda0-d6d1-4ded-8bf5-90ecb8d510a7 33 fields · synced May 30, 2026
- FDA UDI 080379b4-8977-4de4-b3a8-dbd24cb88a36 33 fields · synced May 30, 2026
- FDA UDI b756bddd-7223-4d15-961b-cadbdc6d82dd 33 fields · synced May 30, 2026
- EUDAMED 7b89aabf-61a5-40db-9ea1-e1d60d9e3656 61 fields · synced Jul 10, 2026
- EUDAMED 60e23574-5517-4be3-8d25-e7fb127ebada 61 fields · synced Jul 10, 2026
- EUDAMED 88babea5-d325-4eab-93d3-dcc5c793bb8e 61 fields · synced Jul 20, 2026
- EUDAMED 60efbc43-0800-4c88-83c4-f915b7faab56 61 fields · synced Jul 25, 2026
- EUDAMED 1c4921c0-c1a3-401b-94ef-8bac59f109cb 61 fields · synced Jul 31, 2026
- EUDAMED 67446c82-3675-438f-ad1e-d14fcb6656a8 61 fields · synced Sep 18, 2026
- EUDAMED 0c483f1f-3c07-4c40-9fce-a7135cf82423 61 fields · synced Sep 30, 2026