FDA UDI
In Commercial Distribution
🇺🇸 United States
GENTLECATH AIR
DI: 00768455196180
·
Model: 510687
·
CONVATEC, PURCHASING DEPARTMENT
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- GENTLECATH AIR
- Primary DI
- 00768455196180
- Version / Model
- 510687
- Company Name
- CONVATEC, PURCHASING DEPARTMENT
- Labeler DUNS
- 809784593
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-07-01
- Public Version
- 2
- Public Version Date
- 2023-03-24
- Public Version Status
- Update
- Public Device Record Key
- 1c24833f-e5c3-45ac-aa42-1560a9b8645b
Device Description
GENTLECATH AIR MEN CH08 (1x30PK) US
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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GBM | Catheter, Urethral | Gastroenterology, Urology | 876.5130 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45603 | Single-administration urethral drainage catheter | A sterile, flexible tube intended to be inserted one-time through the urethra to the urinary bladder, by the patient/user or a healthcare provider, to provide urine drainage, typically for an individual who is physiologically incapable of voiding. It is typically made of polyvinyl chloride (PVC), and may be coated with a lubricating substance (e.g., acquires a smooth and mucous surface when brought in contact with water). The distal end can have various tip designs [e.g., open-ended, rounded with a side hole(s)], and the proximal end typically connects to a urine collection container. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00768455196197 | GS1 | Inner Carton | 30 | In Commercial Distribution | |
| Primary | 00768455196180 | GS1 | ||||
| Package | 00768455196203 | GS1 | Shipper | 8 | In Commercial Distribution |
Customer Contacts
- Phone
- +18004228811
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K213283 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Length | 365 | Millimeter | |
| Catheter Gauge | 08 | French |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Protect from Sunlight