FDA UDI
In Commercial Distribution
🇺🇸 United States
SpeediCath Standard
DI: 05708932020596
·
Model: 28708
·
Coloplast A/S
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- SpeediCath Standard
- Primary DI
- 05708932020596
- Version / Model
- 28708
- Catalog Number
- 28708
- Company Name
- Coloplast A/S
- Labeler DUNS
- 305524696
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-02
- Public Version
- 5
- Public Version Date
- 2024-03-19
- Public Version Status
- Update
- Public Device Record Key
- e70377be-c31e-4efc-b671-fd91904055fb
Device Description
SpeediCath Standard. Urinary catheter for intermittent catheterization. Ready to use coated catheter. Nelaton. Pediatric. FR 8/2.7 mm. Rx only.
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
- 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
- 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 | 05708932640480 | GS1 | Retail Box | 30 | In Commercial Distribution | |
| Primary | 05708932020596 | GS1 | ||||
| Package | 05708932640473 | GS1 | Shipper Box | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800)533-0464
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 8 | French | |
| Catheter Working Length | 6.3 | Inch | |
| Device Size Text, specify | Tip Type Straight/Nelaton | ||
| Catheter Working Length | 16 | Centimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight. Do not use if package is damaged and consult IFU.