Identity
- Trade Name
- Medline FDA UDI
- Generic Name
- Gas-sampling/monitoring respiratory tubing, single-use FDA UDI
- Device Name
- CO2 CAN,ADLT,MICROFILTER,EXTD,7',ORL/NSL FDA UDI
- Model / Reference
- HCSE4607MO FDA UDI
- Description
- CO2 CAN,ADLT,MICROFILTER,EXTD,7',ORL/NSL FDA UDI
Identifiers
- Catalog Number
- HCSE4607MO FDA UDI
- Primary DI / UDI-DI
- 10193489028003 FDA UDI
- 510(k) Number
- K063813 FDA UDI
- FDA Product Code
- CCK FDA UDI
- GMDN Term
- Gas-sampling/monitoring respiratory tubing, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1400 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
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
No
FDA UDI
Category: Gas-sampling/monitoring respiratory tubing, single-use
Medline by Medline Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K063813 also covers:
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
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 II | Pending data |
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Manufacturer
- Manufacturer
- Medline Industries, Inc.
Sources (1)
- FDA UDI 71f054c5-32b4-4e36-aadc-39d0c650af00 36 fields · synced Jun 6, 2026