Catheter Packaging for Indian Medical Device Exporters

A standard catheter pack typically includes the catheter itself, a sterile drape, gloves, antiseptic solution or wipes, a collection bag or drainage tube, and sometimes a pre-filled syringe for balloon inflation. At our Cedar Park facility, we assemble custom catheter kits with whichever components your product line requires—so India-based exporters can ship compact and let us build US-ready kits under sterile, FDA-compliant conditions.

Yes. Blue Bonnet Supplies operates with FDA-cleared medical packaging built into our standard workflow. Every catheter packaging process at our Cedar Park, TX facility adheres to FDA, ISO 13485, and GMP standards—sterile packaging, tamper-evident seals, accurate labeling, UDI marking, and compliant documentation—so your India-made devices meet US regulatory requirements, with your CDSCO free-sale certificate supporting FDA establishment registration and device listing.

Yes, we provide sterile packaging solutions specifically designed for medical devices like catheters—sterile pouches, tamper-evident seals, and clean handling procedures aligned with GMP and ISO 13485 standards. Our facility is structured to maintain the integrity of sterile medical products from packaging through storage and final US shipment, ideal for India-based device makers shipping in bulk.

Absolutely. Our kitting services assemble catheters and accompanying components into complete, procedure-ready kits based on your requirements. Each kit is assembled accurately, packaged to maintain sterility, labeled with compliant product information and UDI, and readied for shipment to US hospitals, clinics, Amazon FBA, or direct-to-consumer channels—so exporters ship components compact and we build kits stateside.

Yes. Once your import clears US customs, our fulfillment supports Amazon FBA for medical supplies, including catheters. We handle FDA-compliant labeling, FNSKU barcoding, proper packaging, and inventory management so your products meet Amazon's requirements and reach customers accurately and on time—without your team managing the fulfillment details from India.

Yes. We coordinate inbound air and ocean consolidation from BOM, DEL, or BLR and the US customs entry—CBP Form 5106, a customs bond, and a licensed broker, no US LLC required. For catheter products we manage customs documentation and FDA-compliant import requirements, then ship domestically across the US and onward internationally, preventing delays at entry so your devices arrive safely.

Our catheter packaging adheres to FDA-cleared packaging standards, ISO 13485, GMP, and HIPAA-safe handling where applicable. These are embedded directly into our daily warehouse, packaging, and fulfillment operations. For India-based exporters, this is the US-side rigor that pairs with your CDSCO documentation to satisfy FDA expectations on 510(k)-cleared or listed devices—compliance built into every step, not an add-on.

Our product testing and restoration service covers returned catheter items. Each return is inspected and evaluated against safety and usability standards at our Texas facility. Items meeting the required criteria are restored to sellable US inventory, helping India-based exporters recover value locally instead of shipping stock back across the ocean. Medical products follow strict protocols before re-entering the supply chain.