FDA UDI
In Commercial Distribution
🇺🇸 United States
Alaris, SmartSite
DI: 10885403274220
·
Model: 41176E
·
BD Switzerland Sàrl
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Alaris, SmartSite
- Primary DI
- 10885403274220
- Version / Model
- 41176E
- Catalog Number
- 41176E
- Company Name
- BD Switzerland Sàrl
- Labeler DUNS
- 482631558
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-22
- Public Version
- 11
- Public Version Date
- 2025-12-18
- Public Version Status
- Update
- Public Device Record Key
- 0aa045eb-ec41-46ad-ad5e-56c944846d12
Device Description
Gravity Set 2 Needle-Free Valves Vented/Nonvented
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 |
|---|---|---|---|---|
| LHI | Set, i.V. Fluid transfer | General Hospital | 880.5440 | 2 |
| FPA | Set, administration, intravascular | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58977 | Basic intravenous administration set, noninvasive | A collection of noninvasive devices intended to conduct fluids from an intravenous (IV) administration bag/bottle to a peripheral venous cannula (not included) during gravitational or pump administration to a patient's venous system; some types may in addition be intended for enteral feeding applications. It typically includes tubing, connectors, chambers, and clamps; the bag/bottle may be included. It neither includes devices intended for invasive use nor a heat exchanger. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10885403274220 | GS1 | ||||
| Secondary | H37041176E1 | HIBCC | ||||
| Package | 50885403274228 | GS1 | Case | 100 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(844)823-5433
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Size = Priming Volume = 21 millilitre (mL) | ||
| Length | 105 | Inch |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Fragile, handle with care
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 125 Degrees Fahrenheit