FDA UDI
Not in Commercial Distribution
🇺🇸 United States
PECO
DI: 10817668010503
·
Model: PU006
·
PECO MEDICAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
30
Basic Information
- Brand Name
- PECO
- Primary DI
- 10817668010503
- Version / Model
- PU006
- Company Name
- PECO MEDICAL INC.
- Labeler DUNS
- 080120792
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 30
- Record Status
- Published
- Publish Date
- 2017-09-08
- Public Version
- 4
- Public Version Date
- 2021-08-17
- Public Version Status
- Update
- Public Device Record Key
- e03e72fc-ff9b-42e4-9030-828dfa6efe2f
- Distribution End Date
- 2020-01-10
Device Description
Box PECO™ 10" Pediatric, 6 Fr. Straight Intermittent Catheter
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
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
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 |
|---|---|---|---|---|---|---|
| Primary | 10817668010503 | GS1 | ||||
| Unit of Use | 00817668010506 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K111405 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 10 | Inch | |
| Catheter Gauge | 6 | French |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 59 – 86 Degrees Fahrenheit