Identity
- Trade Name
- IMed Products FDA UDI
- Generic Name
- Basic intravenous administration set, noninvasive FDA UDI
- Device Name
- IMed EVA Gravity Bag, 2000ml, 2 Legs FDA UDI
- Model / Reference
- IM68105 FDA UDI
- Description
- IMed EVA Gravity Bag, 2000ml, 2 Legs FDA UDI
Identifiers
- Catalog Number
- IM68105 FDA UDI
- Primary DI / UDI-DI
- 20853155008339 FDA UDI
- 510(k) Number
- K030888 FDA UDI
- FDA Product Code
- KPE FDA UDI
- GMDN Term
- Basic intravenous administration set, noninvasive FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5025 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Basic intravenous administration set, noninvasive
IMed Products by Integrated Medical Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K030888 also covers:
- IMed Products — INTEGRATED MEDICAL SYSTEMS, INC.
- IMed Products — INTEGRATED MEDICAL SYSTEMS, INC.
- IMed Products — INTEGRATED MEDICAL SYSTEMS, INC.
- IMed Products — INTEGRATED MEDICAL SYSTEMS, INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- CORMIX — METRIX COMPANY, THE
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
- Integrated Medical Systems, Inc.
Sources (1)
- FDA UDI 874445cd-49f8-44eb-a404-0d686603fe45 35 fields · synced May 30, 2026