Spire Biomedical, Inc.

All lot codes

Gastroenterology-Urology Devices

2

Yes

Worldwide distribution - Nationwide, Government. Foreign: Canada, France.

36CM DECATHLON FUNNEL TIP STD KIT || Model: DF31SH36 || DECATHLON FUNNEL TIP || 15.5 Fr polyurethane twin lumen hemodialysis catheter with separated funnel tips, cuff and side holes for chronic hemodialysis and || apheresis. Kit contains catheter with stylet, 18 gauge introducer needle, 12cc syringe, J/straight 0.038 inch guidewire, 12Fr dilator, || 14Fr dilator, 16Fr peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze sponges, wound dressing, (2) injection sealing caps, and warning label. Latex free

All lot codes

Gastroenterology-Urology Devices

2

Yes

Worldwide distribution - Nationwide, Government. Foreign: Canada, France.

40CM DECATHLON FUNNEL TIP STD KIT || Model: DF35SH40 || DECATHLON FUNNEL TIP || 15.5 Fr polyurethane twin lumen hemodialysis catheter with separated funnel tips, cuff and side holes for chronic hemodialysis and || apheresis. Kit contains catheter with stylet, 18 gauge introducer needle, 12cc syringe, J/straight 0.038 inch guidewire, 12Fr dilator, || 14Fr dilator, 16Fr peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze sponges, wound dressing, (2) injection sealing caps, and warning label. Latex free.

All lot codes

Gastroenterology-Urology Devices

2

Yes

Worldwide distribution - Nationwide, Government. Foreign: Canada, France.

32CM DECATHLON GOLD STD KIT || Models: DEC27SH32 and DEC27SH32-K || DECATHLON GOLD || 15.5 Fr polyurethane twin lumen Heparin coated hemodialysis catheter with separated tips, cuff and side holes for chronic || hemodialysis and apheresis. Kit contains catheter, 18 gauge introducer needle, 12cc syringe, J/straight 0.038 inch guidewire, 12Fr || dilator, 14Fr dilator, 16Fr peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze sponges, wound dressing, (2) injection sealing caps, and warning label. Latex free.

All lot codes

Gastroenterology-Urology Devices

2

Yes

Worldwide distribution - Nationwide, Government. Foreign: Canada, France.

32CM ALTA EXCHANGE || Model: AL27SH32 XP || ALTA EXCHANGE KIT || 15.5 Fr polyurethane twin lumen fixed tip hemodialysis catheter, cuff and side holes for chronic hemodialysis and apheresis. Latex free

All lot codes

Gastroenterology-Urology Devices

2

Yes

Worldwide distribution - Nationwide, Government. Foreign: Canada, France.

28CM DECATHLON FUNNEL TIP STD KIT || Model: DF23SH28 || DECATHLON FUNNEL TIP || 15.5 Fr polyurethane twin lumen hemodialysis catheter with separated funnel tips, cuff and side holes for chronic hemodialysis and || apheresis. Kit contains catheter with stylet, 18 gauge introducer needle, 12cc syringe, J/straight 0.038 inch guidewire, 12Fr dilator, || 14Fr dilator, 16Fr peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze sponges, wound dressing, (2) injection sealing caps, and warning label. Latex free.