FDA UDI
In Commercial Distribution
🇺🇸 United States
Alaris, SmartSite
DI: 07613203011792
·
Model: 2203E
·
BD Switzerland Sàrl
Product Codes
1
GMDN Terms
2
Identifiers
4
Pkg Device Count
1
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Basic Information
- Brand Name
- Alaris, SmartSite
- Primary DI
- 07613203011792
- Version / Model
- 2203E
- Catalog Number
- 2203E
- 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
- 7
- Public Version Date
- 2025-07-31
- Public Version Status
- Update
- Public Device Record Key
- 1e6f7c31-1302-4f46-9a1a-c4d27038c9be
Device Description
13mm Vial Access Device, Needle-Free Valve, 3.5 cm (1.5 in)
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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35833 | Electric infusion pump administration set, single-use | A collection of sterile devices (e.g., plastic tubing, check valve, roller clamp, Y-site connector, Luer, needle/catheter) intended to be used in combination with an electrically-powered infusion pump for the intravenous (IV), subcutaneous, intramuscular, or epidural administration of medication. This is a single-use device. | No | Active |
| 60450 | Intra-abdominal pressure measurement set, electronic | A collection of sterile devices intended to electronically measure intra-abdominal pressure (IAP) through the bladder. It typically includes an electronic pressure transducer, syringe, tubing, connectors, and a urine collection bag. The assembled device is connected to an indwelling urethral catheter (Foley), saline is infused into the bladder and IAP is measured by the transducer and displayed on, and powered by, a wire-connected monitor. It is typically used for patients at risk of intra-abdominal hypertension (IAH) e.g., following abdominal surgery/trauma. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 37613203011809 | GS1 | Case | 2 | In Commercial Distribution | |
| Primary | 07613203011792 | GS1 | ||||
| Package | 27613203013851 | GS1 | Box | 50 | In Commercial Distribution | |
| Secondary | H3702203E14 | HIBCC |
Customer Contacts
- Phone
- +1(844)823-5433
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Size = Priming Volume = 0.08 millilitre (mL) | ||
| Length | 1.5 | Inch |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight
- Type
- Special Storage Condition, Specify
- Special Conditions
- Fragile, handle with care
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 125 Degrees Fahrenheit