FDA UDI
In Commercial Distribution
🇺🇸 United States
SeromaCath
DI: 00854373007032
·
Model: 1035 Pouch
·
GREER MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- SeromaCath
- Primary DI
- 00854373007032
- Version / Model
- 1035 Pouch
- Catalog Number
- 1035
- Company Name
- GREER MEDICAL, INC.
- Labeler DUNS
- 800169260
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-10
- Public Version
- 4
- Public Version Date
- 2022-03-08
- Public Version Status
- Update
- Public Device Record Key
- 671eae60-8564-46d3-a712-3babc44f0065
Device Description
Long SeromaCath Wound Drainage System 14G (2,1mm) x 3.5" (8,9cm)
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
- No
- 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 |
|---|---|---|---|---|
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | General, Plastic Surgery | 878.4680 | 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 |
|---|---|---|---|---|---|---|
| Package | 00854373007025 | GS1 | Box | 5 | In Commercial Distribution | |
| Primary | 00854373007032 | GS1 |
Customer Contacts
- Phone
- 805-962-5883
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K905733 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Catheter Gauge: 14: Gauge | ||
| Length | 3.5 | Inch |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 33 – 105 Degrees Fahrenheit
- Type
- Handling Environment Temperature
- Temperature Range
- 50 – 90 Degrees Fahrenheit