SeromaCath 1035
GUDID 00854373007025
Long SeromaCath Wound Drainage System 14G (2,1mm) x 3.5" (8,9cm)
GREER MEDICAL, INC.
Closed-wound drain| Primary Device ID | 00854373007025 |
| NIH Device Record Key | 671eae60-8564-46d3-a712-3babc44f0065 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SeromaCath |
| Version Model Number | 1035 Pouch |
| Catalog Number | 1035 |
| Company DUNS | 800169260 |
| Company Name | GREER MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 805-962-5883 |
| info@greer-medical.com | |
| Phone | 805-962-5883 |
| info@greer-medical.com | |
| Phone | 805-962-5883 |
| info@greer-medical.com | |
| Phone | 805-962-5883 |
| info@greer-medical.com | |
| Phone | 805-962-5883 |
| info@greer-medical.com | |
| Phone | 805-962-5883 |
| info@greer-medical.com | |
| Phone | 805-962-5883 |
| info@greer-medical.com | |
| Phone | 805-962-5883 |
| info@greer-medical.com | |
| Phone | 805-962-5883 |
| info@greer-medical.com | |
| Phone | 805-962-5883 |
| info@greer-medical.com | |
| Phone | 805-962-5883 |
| info@greer-medical.com | |
| Phone | 805-962-5883 |
| info@greer-medical.com | |
| Phone | 805-962-5883 |
| info@greer-medical.com | |
| Phone | 805-962-5883 |
| info@greer-medical.com | |
| Phone | 805-962-5883 |
| info@greer-medical.com | |
| Phone | 805-962-5883 |
| info@greer-medical.com | |
| Phone | 805-962-5883 |
| info@greer-medical.com |
Device Dimensions
| Length | 3.5 Inch |
| Length | 3.5 Inch |
| Device Size Text, specify | 0 |
| Length | 3.5 Inch |
| Device Size Text, specify | 0 |
| Length | 3.5 Inch |
| Device Size Text, specify | 0 |
| Length | 3.5 Inch |
| Device Size Text, specify | 0 |
| Length | 3.5 Inch |
| Device Size Text, specify | 0 |
| Length | 3.5 Inch |
| Device Size Text, specify | 0 |
| Length | 3.5 Inch |
| Device Size Text, specify | 0 |
| Length | 3.5 Inch |
| Device Size Text, specify | 0 |
| Length | 3.5 Inch |
| Device Size Text, specify | 0 |
| Length | 3.5 Inch |
| Device Size Text, specify | 0 |
| Length | 3.5 Inch |
| Device Size Text, specify | 0 |
| Length | 3.5 Inch |
| Device Size Text, specify | 0 |
| Length | 3.5 Inch |
| Device Size Text, specify | 0 |
| Length | 3.5 Inch |
| Device Size Text, specify | 0 |
| Length | 3.5 Inch |
| Device Size Text, specify | 0 |
| Length | 3.5 Inch |
| Device Size Text, specify | 0 |
| Length | 3.5 Inch |
Operating and Storage Conditions
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 105 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 105 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 105 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 105 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 105 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 105 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 105 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 105 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 105 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 105 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 105 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 105 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 105 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 105 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 105 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 105 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00854373007025 [Package] Contains: 00854373007032 Package: Box [5 Units] In Commercial Distribution |
| GS1 | 00854373007032 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K905733
FDA Product Code
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-05-10 |
On-Brand Devices [SeromaCath]
| 00854373007056 | Blunt SeromaCath Wound Drainage System 14G (2,1mm) x 2" (5cm) |
| 00854373007025 | Long SeromaCath Wound Drainage System 14G (2,1mm) x 3.5" (8,9cm) |
| 00854373007001 | Original SeromaCath Wound Drainage System 14G (2,1mm) x 2" (5cm) |
Trademark Results [SeromaCath]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SEROMACATH 74122040 1702467 Live/Registered |
GREER MEDICAL, INC. 1990-12-10 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.