Procedure Packs, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Procedure Packs, Inc. makes
Procedure Packs, Inc. manufactures sterile, single-use administration sets for medical procedures, including pressure-monitored lines, contrast media infusion kits, and intravenous solution delivery systems. These products are designed for use in diagnostic imaging, radiology, and procedural interventions requiring precise fluid administration.
The company’s products are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearance records. These devices are listed in the FDA’s 510(k) database and comply with U.S. regulatory requirements for sterile, disposable medical accessories.
Catalogue
Angiography Custom Packs Ref K891572
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Procedure Packs Solution Administration Sets Ref K882716
Regimes: 510(k) Registry: 510(k)Procedure Packs Contrast Media Sets Ref K882717
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Procedure Packs, Inc. have in the registry?
The registry currently lists 4 devices for Procedure Packs, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Procedure Packs, Inc.'s devices?
Among its 4 most recently registered devices, Procedure Packs, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Procedure Packs, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Procedure Packs, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Procedure Packs, Inc. in the registry?
The most recently registered devices listed for Procedure Packs, Inc. include ANGIOGRAPHY CUSTOM PACKS, PROCEDURE PACKS PRESS. MONITOR/ADMINISTRATION LINE, PROCEDURE PACKS SOLUTION ADMINISTRATION SETS and PROCEDURE PACKS CONTRAST MEDIA SETS.