FDA UDI
In Commercial Distribution
🇺🇸 United States
AVANOS
DI: 00193494135355
·
Model: 13535
·
Avanos Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- AVANOS
- Primary DI
- 00193494135355
- Version / Model
- 13535
- Catalog Number
- PM020-A
- Company Name
- Avanos Medical, Inc.
- Labeler DUNS
- 079375431
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-03
- Public Version
- 1
- Public Version Date
- 2020-07-13
- Public Version Status
- New
- Public Device Record Key
- 6b36484b-e5e3-4225-bbca-e73fe040ab77
Device Description
ON-Q* Antimicrobial Expansion Kits with SILVERSOAKER* Catheter 5 in (12.5 cm), Needle 6 in x 17 GA
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| BSO | CATHETER, CONDUCTION, ANESTHETIC | Anesthesiology | 868.5120 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46383 | Peripheral anaesthesia catheter set, non-medicated | A collection of devices intended for the continuous-administration of an anaesthetic agent (not included) to function as a peripheral nerve-block. It includes an anaesthesia needle and an anaesthesia catheter usually with additional devices utilized for the procedure (e.g., connectors, catheter holder). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10193494135352 | GS1 | CS | 5 | In Commercial Distribution | |
| Primary | 00193494135355 | GS1 |
Customer Contacts
- Phone
- +1(844)428-2667
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K051401 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 5 | Inch | |
| Device Size Text, specify | Catheter Soaker Length (in) |