FDA UDI
In Commercial Distribution
🇺🇸 United States
Safety Drain line adapter
DI: 00628725047638
·
Model: M7010
·
Canadian Hospital Specialties Limited
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Safety Drain line adapter
- Primary DI
- 00628725047638
- Version / Model
- M7010
- Catalog Number
- M7010
- Company Name
- Canadian Hospital Specialties Limited
- Labeler DUNS
- 240992693
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-17
- Public Version
- 1
- Public Version Date
- 2024-06-25
- Public Version Status
- New
- Public Device Record Key
- 41b4e922-6002-417c-a48a-a5937117346e
Device Description
Safety Drain Line Adapter
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
- Yes
- 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 |
|---|---|---|---|---|
| KGZ | Accessories, Catheter | General, Plastic Surgery | 878.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34924 | Suprapubic drainage catheter | A flexible/semi-rigid tube intended to be inserted through a suprapubic (above the pubic arch) incision directly into the bladder of a patient for the drainage of urine; it may also allow for infusion of fluid (e.g., medication, saline). It typically consists of a straight or angled, single-lumen tube with holes/tips at the distal end (e.g., malecot or pigtail design). The proximal end remains external to the patient and has a connector for connection to a urine collection device. It may include a stiffening device to assist in its insertion; however, it does not include non-dedicated supportive devices (i.e., not a kit). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50628725047633 | GS1 | Corrugate Case | 50 | In Commercial Distribution | |
| Primary | 00628725047638 | GS1 |
Customer Contacts
- Phone
- 9058259300
- [email protected]