FDA Registration
Active
🇺🇸 United States
PROCEDURE PRODUCTS, INC.
Reg #: 3020778
·
FEI: 3020778
·
Expires 2026
Products
8
Proprietary Names
54
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- PROCEDURE PRODUCTS, INC.
- Registration Number
- 3020778
- FEI Number
- 3020778
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1801 WEST 4TH PLAIN BLVD.
- City
- Vancouver
- State
- WA
- ZIP
- 98660
- Country
- US
Regulatory Submissions
- 510(k) Number
- K884985
Owner / Operator
- Firm Name
- Procedure Products, Inc.
- Operator Number
- 3020778
- Address
- 1801 WEST 4TH PLAIN BLVD., --
- City
- Vancouver
- State
- WA
- Postal Code
- 98660
- Country
- US
- Correspondent
- Eric - Dietz
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2007-12-05 |
| Container, I.V. | KPE | Class 2 | General Hospital | No | 2007-12-05 |
| Stopcock, I.V. Set | FMG | Class 2 | General Hospital | No | 2007-12-05 |
| Dilator, Vessel, For Percutaneous Catheterization | DRE | Class 2 | Cardiovascular | No | 2007-12-05 |
| Container, Liquid Medication, Graduated | KYW | Class 1 | General Hospital | No | 2012-08-23 |
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2007-12-05 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2007-12-05 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2007-12-05 |
Proprietary Names
Polycarbonate and Class VI colors Sterile/Non-sterile
05cc/ml, 10cc/ml and 20cc/ml Plungers for standard BD size barrels and stoppers
Syringe, Control and Satndard Color Coded Plungers
Along with the polypropylene material
4770 - 1-way stopcock 4¿ tubing and spike
Bag Spigots ¿ I.V. Plumbing Adapters ¿ Sterile and Non-sterile
91-722 Univeral Macro Chamber w/ 72¿ line
4722 ¿ Spike with Female luer lock
4771 - 3-way stopcock 4¿ tubing and spike
47-722 Universal Spike w/72¿ line
4721 - Spike with Male Luer Lock
4710 ¿ Bag Spigot with non-vented spike
4709 ¿ Bottle Spigot universal vented spike
Polycarbonate - Resin - Polyethylene
! way - 3 way Lock - Slip - Fixed - Configurations
Disposable Stopcock - Sterile and Non-sterile
Needles, Single Use Catheterization
Modified Seldinger Arterial, Chiba, Seldinger without plate, Potts Cournand,
SDN 18 ga., 19 ga., 21 ga., Special Procedure
Ultra Modified Seldinger, U-KSDN 19 ga. Special , U-SDN 19 ga. Special
Legths 1.50 to 9 in., Accepts 15 to 38 wires
Ampllatz, BSDN 18 ga., 19 ga., Modified Potts Cournand, KSDN 18 ga.,
Syringe, Control and Standard Color Coded Plungers
Polypropylene material and Class VI colors Sterile/Non-sterile
Freedom Syringe
4oz cups, 3004-color
2oz cups, 3002-color
8oz cups, 3008-color
16oz cups, 3016-color
32oz cups, 3032-color
4oz cups, 3004-color with lid
Color Coded, Blue, Red, Yellow, Green and Semi-clear 2oz cups, 4oz cups with lids, 8oz cups, 16oz cups, sterile and non
Polyurethane Lines, Braided Lines, Injector Lines, Pressure Monitoring Lines
High Pressure, Standard Pressure Lines
Male/Female, Female/Female, Male/Male Configurations
Roentgenography Sets and/or Connecting Sets
Sizes: OD .110, .140, .155, .187 and .215 Fixed and Rotator ends
1200 PSI, 1000 PSI, 500 PSI and below
10¿, 12¿, 15¿, 20¿ 24¿, 30¿, 36¿, 48¿, 60¿ and 72¿ Lengths
8022 and 8035
4803 ¿ 1000cc/ml or above waste bag with female lock
4571 ¿ Waste Bag System and Stopcock with Dual Check Valve ¿ Bonded/Attachable
4502 - Waste Bag System with Dual Check Valve Bonded
Waste Bag Systems ¿ Sterile and Non-Sterile
4512 ¿ Waste Bag System with Dual Check Vale and Macro Drip ¿ Bonded or Attachable
4822 ¿ Waste Bag with dual Check valve and 10¿ line ¿ Bonded or Attachable
4801 ¿ 1000cc/ml or above waste bag w/ male lock
4559 ¿ Waste Bag System with Dual Check Valve Attachable
Luers - ANSI Standards
OD. .110, .140, .150, .187, 215
Adaptors - catheter - 8039, 8038, 8037, 8042, 8033, 8012
Male/Female, Female/Female, Male/Male, Rotating - Fixed
Luer Plug/Ends for General Hospital/ OEM Use
Ends and Plugs to close ports - Sterrle/Non-sterile
Establishment Types
Manufacture Medical Device