FDA UDI
In Commercial Distribution
🇺🇸 United States
Axiom® Dual-Sump Atraum™ With ClotStop®
DI: M665111187AT0
·
Model: 111187AT
·
AXIOM MEDICAL, INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Axiom® Dual-Sump Atraum™ With ClotStop®
- Primary DI
- M665111187AT0
- Version / Model
- 111187AT
- Company Name
- AXIOM MEDICAL, INCORPORATED
- Labeler DUNS
- 094439676
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-23
- Public Version
- 1
- Public Version Date
- 2018-10-24
- Public Version Status
- New
- Public Device Record Key
- 494cd366-5c9d-47bc-91c5-0787ed0b6329
Device Description
Sump Drain, Three Lumens, Silicone, Small Eye, With Filter, With ClotStop®
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
- No
- 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 |
|---|---|---|---|---|
| GBS | Catheter, Ventricular, General & Plastic Surgery | General, Plastic Surgery | 878.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15270 | Sump drain | A sterile, tube-like device that has a double lumen which is designed to establish a channel for the removal of fluids from a cavity by allowing air to enter the cavity through the smaller lumen which displaces fluid into the larger lumen. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | M665111187AT3 | HIBCC | Case | 6 | In Commercial Distribution | |
| Package | M665111187AT1 | HIBCC | Box | 10 | In Commercial Distribution | |
| Primary | M665111187AT0 | HIBCC |
Customer Contacts
- Phone
- 310-533-9020
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K883887 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 14 | Inch | |
| Lumen/Inner Diameter | 8.5 | Millimeter |