FDA UDI
In Commercial Distribution
🇺🇸 United States
ARROW
DI: 10801902126679
·
Model: IPN040171
·
TELEFLEX INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- ARROW
- Primary DI
- 10801902126679
- Version / Model
- IPN040171
- Catalog Number
- LR-05502
- Company Name
- TELEFLEX INCORPORATED
- Labeler DUNS
- 002348191
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-16
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 771cb422-9858-4366-bebd-e4d6c8417f44
Device Description
5 mL Luer-Slip Loss of Resistance Syringe
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- Yes
- 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
- 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 |
|---|---|---|---|---|
| FMF | Syringe, piston | General Hospital | 880.5860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60116 | DNA-based tissue typing IVD, control | A material which is used to verify the performance of an assay intended to be used to evaluate a clinical specimen to diagnose or predict donor and recipient tissue compatibility based on one or multiple genetic markers from the major histocompatibility complex (MHC) family of genes. Genetic markers may include HLA-A, HLA-B, HLA-C, DRB1, DRB3, DRB4, DRB5, DQB1, DPB1, MICA and/or C4. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30801902126673 | GS1 | Case | 25 | In Commercial Distribution | |
| Primary | 10801902126679 | GS1 |
Customer Contacts
- Phone
- +1(919)544-8000
- [email protected]