Volumetric Incentive Spirometer 5000ml

EUDAMEDFDA UDIFDA 510(k)

Class IIa (EU MDR)

Ref TB-93500Model TB-93100

by Besmed Health Business Corp.

Identity

Trade Name: Volumeteric Incentive Spirometer 5000 ml EUDAMED
INCENTIVE SPIROMETER,5000ML FDA UDI
Generic Name: Incentive spirometer FDA UDI
Device Name: Volumetric Incentive Spirometer 5000ml EUDAMED
Incentive Spirometer (Flow rate) EUDAMED
Model / Reference: TB-93500 EUDAMEDFDA UDI
TB-93100 EUDAMED

Identifiers

Primary DI / UDI-DI: D-TB-935002M EUDAMED
04716770935003 EUDAMEDFDA UDI
Basic UDI-DI: B-TB-935002M EUDAMED
4716770TB09300HA EUDAMED
Direct Marketing DI: 04716770935003 EUDAMED
510(k) Number: K141355 FDA UDI
FDA Product Code: BWF FDA UDI
EMDN Code: Z12150102 PEAK FLOW SPIROMETERS EUDAMED
GMDN Term: Incentive spirometer FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class I EUDAMED
Class II FDA UDI
Regulation Number: 868.5690 FDA UDI
Market of Registration: Lithuania EUDAMED
Belgium EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMEDEUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Expiratory peak flow meter, digital

Volumetric Incentive Spirometer 5000ml by Besmed Health Business Corp. — Class IIa — MDR, FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k)

Similar devices

Also classified as Expiratory peak flow meter, digital.

Model 4000 — Vitalograph Ireland, Ltd. · Class II
Spirolab — MIR - Medical International Research S.p.A. · Class IIa
Spirolab Plus — MIR - Medical International Research S.p.A. · Class IIa
NxGen Peak Flow Meter — SAFEY MEDICAL DEVICES PRIVATE LIMITED · Class II
Spirosound — Medset Medizintechnik GmbH · Class IIa
Model 4000 — Vitalograph Ireland, Ltd. · Class II
Model 4000 — Vitalograph Ireland, Ltd. · Class II
Model 4000 — Vitalograph Ireland, Ltd. · Class II

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Active

FDA_510K

European Union Active

CE/MDD

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	B-TB-935002M	Class IIa	Active
FDA 510(k)	United States	FDA_510K	K141355	Class IIa	Active
EUDAMED	European Union	CE/MDD	B-TB-935002M	Class IIa	Active

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Manufacturer

Manufacturer: Besmed Health Business Corp.
EUDAMED SRN: TW-MF-000007246
Authorised Representative: mdi Europa GmbH DE-AR-000006218

Sources (4)

EUDAMED af1ad3c8-bd24-4c97-82e3-ec5459da7d88 61 fields · synced Jun 19, 2026
FDA UDI 3f478f23-5081-4185-a99a-ee31d32da15c 33 fields · synced May 30, 2026
EUDAMED b65f1291-a869-4948-973e-aa0ca334144a 61 fields · synced Jun 19, 2026
FDA 510(k) K141355 1 fields · synced May 18, 2026