Identity
- Trade Name
- MEDLINE FDA UDI
- Generic Name
- Nebulizing system delivery set, single-use FDA UDI
- Device Name
- COMPRESSOR, REUS, PED MASK FDA UDI
- Model / Reference
- HCS70004XP FDA UDI
- Description
- COMPRESSOR, REUS, PED MASK FDA UDI
Identifiers
- Catalog Number
- HCS70004XP FDA UDI
- Primary DI / UDI-DI
- 10197344154180 FDA UDI
- FDA Product Code
- BTI FDA UDI
- GMDN Term
- Nebulizing system delivery set, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.6250 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
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Nebulizing system delivery set, single-use
Medline by Medline Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Drive — Drive Devilbiss Healthcare · Class II
- Nebulizer — WESTMED, INC. · Class II
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 f7dc65cc-7a8c-4696-9c5d-1935f4f39b9f 36 fields · synced Jun 8, 2026