FDA UDI
In Commercial Distribution
🇺🇸 United States
SwabSleeve™
DI: 10887709097107
·
Model: SCXT3-5-2000
·
ICU MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
5
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Basic Information
- Brand Name
- SwabSleeve™
- Primary DI
- 10887709097107
- Version / Model
- SCXT3-5-2000
- Catalog Number
- SCXT3-5-2000
- Company Name
- ICU MEDICAL, INC.
- Labeler DUNS
- 118380146
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2024-04-05
- Public Version
- 1
- Public Version Date
- 2024-04-15
- Public Version Status
- New
- Public Device Record Key
- e4046ddd-a75c-426d-a071-c5e5d3be31a0
Device Description
SwabSleeve™
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QBP | Cap, device disinfectant | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61141 | Luer-formatted disinfection cap | A small, noninvasive, closed-ended Luer attachment intended to be attached to a connector in an intravenous line (e.g., needleless valve, Luer access valve, male Luer connector) to disinfect the valve surface and/or maintain disinfection, and for protection. It is a synthetic polymer cap containing a foam material saturated with isopropyl alcohol (IPA) as the disinfectant; it may contain other components. The cap may be removed shortly after disinfection, or remain in place to maintain disinfection for a limited period. This device may be supplied with male Luer end caps (not containing disinfectant) for use on the disconnected IV tubing. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30887709097101 | GS1 | 8 | In Commercial Distribution | ||
| Package | 20887709097104 | GS1 | 50 | In Commercial Distribution | ||
| Primary | 10887709097107 | GS1 | ||||
| Unit of Use | 00887709097100 | GS1 |
Customer Contacts
- Phone
- +1(866)829-9025
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K130975 | 000 |