FDA UDI
Not in Commercial Distribution
🇺🇸 United States
AVANOS
DI: 00609038001029
·
Model: B71011
·
Avanos Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- AVANOS
- Primary DI
- 00609038001029
- Version / Model
- B71011
- Catalog Number
- B71011
- Company Name
- Avanos Medical, Inc.
- Labeler DUNS
- 079375431
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-07
- Public Version
- 3
- Public Version Date
- 2024-03-01
- Public Version Status
- Update
- Public Device Record Key
- e1c11e09-90f0-4368-a2fb-a8170e5b7c5b
- Distribution End Date
- 2024-03-01
Device Description
Replacement Catheter for Neonates / Pediatrics
Device Characteristics
- Single Use
- No
- 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
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| BSY | CATHETERS, SUCTION, TRACHEOBRONCHIAL | Anesthesiology | 868.6810 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34923 | Suction system catheter, general-purpose | A sterile flexible tube used in the removal of fluids from the body via a natural body orifice, surgical incision, or wound. It is typically designed to be attached to a collection canister or bottle where a vacuum is created by a suction system via an intermediate tubing. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20609038001023 | GS1 | CS | 2 | Not in Commercial Distribution | 2024-03-01 |
| Package | 10609038001026 | GS1 | DSP | 10 | Not in Commercial Distribution | 2024-03-01 |
| Primary | 00609038001029 | GS1 |
Customer Contacts
- Phone
- +1(844)428-2667
- [email protected]