iWay iway 13

by Shenzhen Witleaf Medical Electronics Co., Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number06970005397013 UDI-DI	Date3 Apr 2024Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: iWay
Generic Name: Nasopharyngeal airway, single-use
Model / Reference: iway 13

Primary DI / UDI-DI: 06970005397013
FDA Product Code: BTQ
GMDN Term: Nasopharyngeal airway, single-use

Device Class: Class I
Regulation Number: 868.5100
GUDID distribution status: In Commercial Distribution

Other devices from Shenzhen Witleaf Medical Electronics Co., Ltd.

Patient Monitor

Class IIb
Patient Monitor

Class IIb
Patient Monitor

Class IIb
Patient Monitor

Class IIb
Patient Monitor

Class IIb
Patient Monitor

Class IIb

See all devices from Shenzhen Witleaf Medical Electronics Co., Ltd. →

Properties

Sterile
Single Use
Prescription Use
Premarket Exempt
Lot / Batch Number
Expiration Date

Other properties (8)

Implantable: No
Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Serial Number: No
Manufacturing Date: No