FDA UDI
In Commercial Distribution
🇺🇸 United States
AP433-01 INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER, NEEDLELESS Y-SIT
DI: 17290109150533
·
Model: 12000-000-0029
·
EITAN MEDICAL LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- AP433-01 INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER, NEEDLELESS Y-SIT
- Primary DI
- 17290109150533
- Version / Model
- 12000-000-0029
- Catalog Number
- 12000-000-0029
- Company Name
- EITAN MEDICAL LTD
- Labeler DUNS
- 533108028
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-01
- Public Version
- 4
- Public Version Date
- 2022-11-23
- Public Version Status
- Update
- Public Device Record Key
- 7399e0a9-b087-41ca-9ea9-3076a59c5211
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
- No
- 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 | 27290109150530 | GS1 | cardboard box | 20 | In Commercial Distribution | |
| Primary | 17290109150533 | GS1 |
Customer Contacts
- Phone
- 1-800-241-4002
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K123049 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius