Klein-Baker Medical, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Klein-Baker Medical, Inc. makes
Klein-Baker Medical, Inc. manufactures sterile medical kits and devices for neonatal and pediatric care, including lumbar puncture kits, catheterization trays, peritoneal dialysis administration sets, and central venous catheters. Their portfolio also includes umbilical catheters designed for dual-lumen use and peripherally inserted central catheter (PICC) lines tailored for pediatric patients.
The company’s products are classified as Class II medical devices under US regulations and are listed in the FDA’s 510(k) clearance registry. These devices are intended for use in clinical settings requiring precise administration and access for infants and young children, adhering to strict manufacturing and performance standards.
Catalogue
Neo-Care Lumber Puncture Kit Ref K970997
Regimes: 510(k) Registry: 510(k)Neo-Care Catheterization Tray Ref K963867
Regimes: 510(k) Registry: 510(k)Neo-Care Peritoneal Dialysis Administration Set Ref K972731
Regimes: 510(k) Registry: 510(k)Neo-Picc Ref K970434
Regimes: 510(k) Registry: 510(k)Neo-Care Dual Lumen Umbilical Catheter Ref K963972
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Klein-Baker Medical, Inc. have in the registry?
The registry currently lists 5 devices for Klein-Baker Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Klein-Baker Medical, Inc.'s devices?
Among its 5 most recently registered devices, Klein-Baker Medical, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Klein-Baker Medical, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Klein-Baker Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Klein-Baker Medical, Inc. in the registry?
The most recently registered devices listed for Klein-Baker Medical, Inc. include NEO-CARE LUMBER PUNCTURE KIT, NEO-CARE CATHETERIZATION TRAY, NEO-CARE PERITONEAL DIALYSIS ADMINISTRATION SET and NEO-PICC.