FDA UDI
In Commercial Distribution
🇺🇸 United States
Bolus handle - US
DI: 17290109153978
·
Model: 15071-000-0005
·
EITAN MEDICAL LTD
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- Bolus handle - US
- Primary DI
- 17290109153978
- Version / Model
- 15071-000-0005
- Catalog Number
- 15071-000-0005
- Company Name
- EITAN MEDICAL LTD
- Labeler DUNS
- 533108028
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-05-15
- Public Version
- 2
- Public Version Date
- 2022-11-23
- Public Version Status
- Update
- Public Device Record Key
- 13c223c5-2e0b-4260-b54a-e3809040880f
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MRZ | Accessories, Pump, Infusion | General Hospital | 880.5725 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61584 | Infusion pump remote control | A hand-operated electronic unit with a configuration of analogue or digital push-buttons (alphanumeric, colour-, or symbol-coded) designed to control the functions of an infusion pump (e.g., analgesia infusion pump, insulin infusion pump) from a distance via a connected cable or wirelessly [e.g., radio-frequency (RF), infrared (IR) transmission]. It is intended to be operated by the patient or healthcare provider. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 27290109153975 | GS1 | Cardboard box | 42 | In Commercial Distribution | |
| Primary | 17290109153978 | GS1 | ||||
| Direct Marking | 07290109153971 | GS1 | ||||
| Package | 27290109154484 | GS1 | Cardboard box | 10 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K192860 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -40 – 70 Degrees Celsius