Identity
- Trade Name
- SwabSleeve™ FDA UDI
- Generic Name
- Luer-formatted disinfection cap FDA UDI
- Device Name
- SwabSleeve™ FDA UDI
- Model / Reference
- SCXT3-5-2000 FDA UDI
- Description
- SwabSleeve™ FDA UDI
Identifiers
- Catalog Number
- SCXT3-5-2000 FDA UDI
- Primary DI / UDI-DI
- 10887709097107 FDA UDI
- 510(k) Number
- K130975 FDA UDI
- FDA Product Code
- QBP FDA UDI
- GMDN Term
- Luer-formatted disinfection cap FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5440 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: Luer-formatted disinfection cap
SwabSleeve™ by Icu Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K130975 also covers:
- SwabCap™ — ICU MEDICAL, INC.
- SwabCap™ — ICU MEDICAL, INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- Excelsior — MEDLINE INDUSTRIES, INC.
- Excelsior — MEDLINE INDUSTRIES, INC.
- Excelsior — MEDLINE INDUSTRIES, INC.
- Excelsior — MEDLINE INDUSTRIES, INC.
- Excelsior — MEDLINE INDUSTRIES, INC.
- Excelsior — MEDLINE INDUSTRIES, INC.
- PENDING — MEDLINE INDUSTRIES, INC.
- PENDING — MEDLINE INDUSTRIES, INC.
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
- Icu Medical, Inc.
Sources (1)
- FDA UDI e4046ddd-a75c-426d-a071-c5e5d3be31a0 36 fields · synced May 30, 2026