FDA UDI
In Commercial Distribution
🇺🇸 United States
SpeediCath Compact
DI: 05708932653046
·
Model: 28702
·
Coloplast A/S
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
20
Basic Information
- Brand Name
- SpeediCath Compact
- Primary DI
- 05708932653046
- Version / Model
- 28702
- Catalog Number
- 28702
- Company Name
- Coloplast A/S
- Labeler DUNS
- 305524696
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2016-09-01
- Public Version
- 5
- Public Version Date
- 2022-03-21
- Public Version Status
- Update
- Public Device Record Key
- 89519521-3952-47c0-a714-2ccd693d1c3b
Device Description
SpeediCath Compact with SpeediBag. Urinary catheter for intermittent catheterization. Ready to use coated catheter. Nelaton. Male. Incl. 20 x non-sterile urine collection bag. Rx-only.
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
- 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
- No
- 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 | 05708932653053 | GS1 | Shipper box | 10 | In Commercial Distribution | |
| Primary | 05708932653046 | GS1 | ||||
| Unit of Use | 05701780091183 | GS1 |
Customer Contacts
- Phone
- +1(800)533-0464
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K023254 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Male | ||
| Catheter Gauge | 12 | French |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not use if sterile barrier is damaged
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight