FDA UDI
In Commercial Distribution
🇺🇸 United States
Comfort Drain
DI: EAMICDS20010
·
Model: CDS2001
·
AMI Agency for Medical Innovations GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Comfort Drain
- Primary DI
- EAMICDS20010
- Version / Model
- CDS2001
- Catalog Number
- CDS2001
- Company Name
- AMI Agency for Medical Innovations GmbH
- Labeler DUNS
- 303655286
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-11-28
- Public Version
- 2
- Public Version Date
- 2022-03-08
- Public Version Status
- Update
- Public Device Record Key
- 5fd7cc60-c6e2-461b-96b5-36ca02fbd663
Device Description
The Comfort Drain is a flexible, silicone, elastic drain with knotless closure that facilitates drainage of perianal fistulas.
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| GBN | Catheter, Pediatric, General & Plastic Surgery | General, Plastic Surgery | 878.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11305 | Closed-wound drain, non-bioabsorbable | A tube-like, non-bioabsorbable device designed to establish a channel for the removal of fluid or purulent material from a closed-wound or an infected area, typically used with a closed drainage system that applies a low negative pressure through the drain lumen. It is typically made of silicone and comes in various designs/sizes for a variety of surgical applications (e.g., orthopaedic, plastic/reconstructive, neurological, gynaecological, thoracic, cardiovascular, general surgery). It might include disposable devices dedicated to drain insertion/function (e.g., sharp trocar blade, connector), however it does not include any fluid collection bags/containers. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | EAMICDS20010 | HIBCC | ||||
| Package | EAMICDS20011 | HIBCC | 10 | In Commercial Distribution |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 20 – 60 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius