Disposable Medical Hyperinflation System 0413

by SunMed GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number10889483231685 UDI-DI	Date10 Nov 2025Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name: Disposable Medical Hyperinflation System
Generic Name: Pulmonary resuscitator, manual, single-use
Model / Ref / Catalog: 0413

Primary DI / UDI-DI: 10889483231685
FDA Product Code: NHK
GMDN Term: Pulmonary resuscitator, manual, single-use

Device Class: Class II
Regulation Number: 868.5905
GUDID distribution status: In Commercial Distribution

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Properties

Single Use
Prescription Use
Lot / Batch Number
Manufacturing Date

Other properties (10)

Sterile: No
Implantable: No
Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Serial Number: No
Expiration Date: No