FDA UDI
In Commercial Distribution
🇺🇸 United States
AV1027-01 Avoset Microbore set 12222-000-1027
DI: 17290109155996
·
Model: 12222-000-1027
·
EITAN MEDICAL LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- AV1027-01 Avoset Microbore set 12222-000-1027
- Primary DI
- 17290109155996
- Version / Model
- 12222-000-1027
- Catalog Number
- AV1027-01
- Company Name
- EITAN MEDICAL LTD
- Labeler DUNS
- 533108028
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-14
- Public Version
- 1
- Public Version Date
- 2026-04-22
- Public Version Status
- New
- Public Device Record Key
- 6da06386-1ca5-4df7-a484-d81a27be719c
Device Description
MICROBORE INFUSION SET WITH FEMALE LUER LOCK, ADMINISTRATION CASSETTE WITH FREE-FLOW PROTECTION, SLIDE CLAMP, DSPR, AND MALE LUER LOCK WITH BACK CHECK VALVE.
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
- MR Unsafe
- 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 |
|---|---|---|---|---|
| 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 | 27290109155993 | GS1 | 20 | In Commercial Distribution | ||
| Primary | 17290109155996 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K213744 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 30 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 30 Degrees Celsius