FDA UDI
In Commercial Distribution
🇺🇸 United States
Sapphire M.T Infusion Pump Kit – US
DI: 17290109154265
·
Model: 17000-028-0072
·
EITAN MEDICAL LTD
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Sapphire M.T Infusion Pump Kit – US
- Primary DI
- 17290109154265
- Version / Model
- 17000-028-0072
- Catalog Number
- 17000-028-0072
- Company Name
- EITAN MEDICAL LTD
- Labeler DUNS
- 533108028
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-05-11
- Public Version
- 4
- Public Version Date
- 2022-11-23
- Public Version Status
- Update
- Public Device Record Key
- 456d020b-1c4f-40c2-9ecb-d4d1a22984c6
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FRN | Pump, Infusion | General Hospital | 880.5725 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13215 | Bedside infusion pump, single-channel | An electrically-powered, non-ambulatory (bedside) device designed to facilitate the accurate and consistent administration of a single drug/solution which can be delivered via intravenous, subcutaneous, arterial, epidural, and intracavital routes using a dedicated infusion set; it is not dedicated to a specific treatment type. It is used to supply higher pressures than those provided by gravity infusion sets or infusion controllers (e.g., typical flow range of 1 to 999 ml/hour) and delivers solutions from a standard infusion bag or bottle of fluid. It is intended primarily for use at the bedside but typically has internal batteries that enable operation, e.g., during transportation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 27290109154262 | GS1 | Cardboard box | 8 | In Commercial Distribution | |
| Primary | 17290109154265 | GS1 | ||||
| Direct Marking | 07290109154268 | GS1 |
Customer Contacts
- Phone
- 949.288.5480
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K192860 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -40 – 70 Degrees Celsius