FDA UDI
In Commercial Distribution
🇺🇸 United States
PEMCO INC
DI: B15214500
·
Model: 1450
·
PEMCO INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PEMCO INC
- Primary DI
- B15214500
- Version / Model
- 1450
- Catalog Number
- 1450
- Company Name
- PEMCO INC
- Labeler DUNS
- 004217071
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-19
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 6e8b4ef7-c555-4c63-b821-e284269dec90
Device Description
Intracardiac Sucker Set with four Tips - Round, Adult Handle at 30 Degree Angle. Comes with Adult Tips 1450-05 10.5 mm diameter, 1450-06 8.8 mm diameter, 1450-07 8.0 mm diameter, 1450-08 6.4 mm diameter; can also use 1480-03 7.0 mm diameter tip. NOTE: All tips also fit 1480-04 sucker handle. Tips are grooved and slotted to allow for better flow and prevent clogging. Suckers have 3/8" & 1/2" barbed end. * Handles and tips may be ordered as separate items. .
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DTS | Sucker, Cardiotomy Return, Cardiopulmonary Bypass | Cardiovascular | 870.4420 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45254 | Suction cannula, reusable | A rigid or semi-rigid, hand-held, metal or durable plastic tube designed as a conduit for the evacuation (suctioning) of blood, fluids, and other tissue debris directly from the surgical site during a surgical procedure (e.g., open-, plastic-, tissue/bone morcellation surgery). Also known as a suction tube, it is typically a general-purpose device to which the suction system tubing is connected proximally; some types may be attached to a dedicated handpiece that typically have a valve. Dedicated cannula specifically intended for a particular procedure (e.g., bronchial, dental, eye, uterine, oral, and liposuction) are also available. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B15214500 | HIBCC |
Customer Contacts
- Phone
- 12165242990
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 10.5 | Inch | |
| Angle | 30 | degree |