FDA UDI
In Commercial Distribution
🇺🇸 United States
ARROW
DI: 10801902195859
·
Model: IPN920595
·
TELEFLEX INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- ARROW
- Primary DI
- 10801902195859
- Version / Model
- IPN920595
- Catalog Number
- AS-05500
- Company Name
- TELEFLEX INCORPORATED
- Labeler DUNS
- 002348191
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-02
- Public Version
- 4
- Public Version Date
- 2025-02-11
- Public Version Status
- Update
- Public Device Record Key
- 8514330c-1423-4941-a161-135221d8c0b8
Device Description
AC3 Range(TM) IABP
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Safe
- 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 |
|---|---|---|---|---|
| CAZ | Anesthesia conduction kit | Anesthesiology | 868.5140 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63606 | Luer/epidural catheter linear connector | A small, non-powered, noninvasive tubular device with a Luer connection (either lock or slip) at one end and an epidural catheter adapting mechanism at the other end, intended to connect an external device with a Luer connection (e.g., syringe) with an epidural catheter with no pre-existing connector. It is designed to connect over the epidural catheter and seal the connection with either an integrated clamping mechanism or by means of an adhesive port. It does not incorporate a valve, tubing nor puncturing component. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30801902195853 | GS1 | Case | 2 | In Commercial Distribution | |
| Package | 20801902195856 | GS1 | Box | 25 | In Commercial Distribution | |
| Primary | 10801902195859 | GS1 |
Customer Contacts
- Phone
- +1(919)544-8000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K103658 | 000 |