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Insertion Kit with 6” (15cm) Introducer for use with MEGA 7.5Fr. 30 & 40cc IABs
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Insertion Kit with 6” (15cm) Introducer for use with MEGA 7.5Fr. 30 & 40cc IABs FDA UDI
- Generic Name
- Vascular catheter introduction set, nonimplantable FDA UDI
- Device Name
- Insertion Kit with 6” (15cm) Introducer for use with MEGA 7.5Fr. 30 & 40cc IABs FDA UDI
- Model / Reference
- 0884-00-0019-21 FDA UDI
- Description
- Insertion Kit with 6” (15cm) Introducer for use with MEGA 7.5Fr. 30 & 40cc IABs FDA UDI
Identifiers
- Catalog Number
- 0884-00-0019-21 FDA UDI
- Primary DI / UDI-DI
- 10607567108025 FDA UDI
- FDA Product Code
- DSP FDA UDI
- GMDN Term
- Vascular catheter introduction set, nonimplantable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.3535 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ethylene Oxide FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 7.5 French FDA UDI
Category: Vascular catheter introduction set, nonimplantable
Insertion Kit with 6” (15cm) Introducer for use with MEGA 7.5Fr. 30 & 40cc IABs by Datascope Corp. — Class II — FDA UDI — listed in FDA GUDID
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Also classified as Vascular catheter introduction set, nonimplantable.
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- ARROW — TELEFLEX INCORPORATED · Class II
- Demax — Beijing Demax Medical Technology Co., Ltd · Class II
- Demax — Beijing Demax Medical Technology Co., Ltd · 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
- Datascope Corp.
Sources (1)
- FDA UDI e954793c-b9ee-4581-a325-8df157dc4725 36 fields · synced May 31, 2026