Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff (U1683S-C51N); Disposable Neonatal NIBP Cuff (U1684S-C51N); Disposable Neonatal NIBP Cuff (U1685S-C51N)

The Unimed Disposable Neonatal NIBP Cuff (Models U1682S–U1685S-C51N) is a non-sterile, single-patient-use accessory for noninvasive blood pressure measurement in neonates with limb circumferences of 4–15 cm. It is used with compatible oscillometric blood pressure monitors and is disposed of after each patient to reduce cross-contamination risk.

The subject device uses TPU film for the cuff material (versus PVC composite nonwoven in the predicate), employs a single-tube configuration (versus single or dual tubes in the predicate), and covers only neonatal sizes Neonate 2–5 (whereas the predicate covers neonatal, pediatric, and adult sizes). All other components (tubing, hook, loop, pressure limits 0–300 mmHg) are identical to the predicate.

ISO 81060-1:2007, ISO 80601-2-30:2018, ISO 10993-5 (cytotoxicity), ISO 10993-10 (skin sensitization), and ISO 10993-23 (skin irritation). Testing confirmed design specifications and biocompatibility for short-term skin contact.

The subject device is substantially equivalent because it shares the same intended use, application site, pressure range, and non-sterile single-patient-use design as the predicate. Although it narrows the patient population to neonates only and substitutes TPU for PVC in the cuff material, both materials passed equivalent biocompatibility testing. The single-tube design is also not expected to affect safety or effectiveness. All differences are in form factor or material selection, not in fundamental operating principle or safety profile.