FDA UDI
In Commercial Distribution
🇺🇸 United States
AP424-01 MICROBORE ADMINISTRATION SET WITH VENTED/NON-VENTED SPIKE
DI: 17290109154883
·
Model: 12003-000-0024
·
EITAN MEDICAL LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- AP424-01 MICROBORE ADMINISTRATION SET WITH VENTED/NON-VENTED SPIKE
- Primary DI
- 17290109154883
- Version / Model
- 12003-000-0024
- Company Name
- EITAN MEDICAL LTD
- Labeler DUNS
- 533108028
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-14
- Public Version
- 1
- Public Version Date
- 2023-03-22
- Public Version Status
- New
- Public Device Record Key
- 45f752e3-d10e-432f-a91f-0f7030b898b6
Device Description
MICROBORE ADMINISTRATION SET WITH VENTED/NON-VENTED SPIKE, FX ADMINISTRATION CASSETTE, SLIDE CLAMP, BACK CHECK VALVE, Y-SITE AND SPIN MALE LUER LOCK, AND WITH FEMALE LUER LOCK, SLIDE CLAMP AND A BACK CHECK VALV
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
- Yes
- 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 |
|---|---|---|---|---|
| FPA | Set, Administration, Intravascular | 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 |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 27290109154880 | GS1 | Cardboard box | 30 | In Commercial Distribution | |
| Primary | 17290109154883 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K192860 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 30 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 15 – 95 Percent (%) Relative Humidity