ACCY 3550-55 RECHARGE HOLSTER PECTORAL

ACCY 3550
NA - 3550-55

A portable device designed to be worn or carried by a patient/layperson to hold a portable medical device (e.g., long-term recorder, wireless antenna, portable oxygen equipment, urine collection bag, tracheostoma protector, infusion pump) during ambulation or sleep; it is neither designed to hold an invasive tube/catheter to the skin surface (i.e., not a catheter/tube holder), nor to house and protect a device from damage (i.e., not a rigid case/housing). It is typically designed as a wearable bag, pouch, strap, belt, headband, or clothing, or as a trolley with wheels. This is a reusable device.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: OAG

Device Name: Garment, Storage, Peritoneal Dialysis Catheter

Device Class: 1

Physical State: Cloth belt

Definition: To store the external peritoneal catheter portion between treatment sessions and to support, stabilize, and improve the care and cleanliness of the peritoneal catheter and reduce the need to use tape on the skin.

Submission Type ID: 4

Review Panel: GU

Review Code: N/A

Technical Method: Y

Gmp Exempt Flag: Holds the catheter tube in a cloth sleeve wrapped around the patient's abdomen.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: External to the body around the abdomen.

Regulation Number: 890.5050

Third Party Flag: N

Medical Specialty: PM

Device Id: 00613994558589

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A