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3M COMPANY

United States·US-MF-000014086

Last updated September 17, 2026

Information

Country: United States
Address: 2510, Conway Avenue, St.Paul, United States
Website: solventum.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(800)634-2249
PRRC Contact: Harry Janiski
EUDAMED SRN: US-MF-000014086
FDA FEI Number: 2110898
DUNS Number: 830016148

Catalogue (3490)

Page 63 of 70

Device	Model / Reference	Registries	Class	Status
3M™ ESPE™ Iso-Form™	L-42	FDA UDI	Class I	Active
3m™ Espe™	800112	FDA UDI	Class I	Active
3M™ Littmann®	6201	FDA UDI	Class I	Active
3M™ Bair Hugger™	31500	FDA UDI	Class II	Active
Bair Hugger™	81101	FDA UDI	Class II	Active
3M™ Littmann® Cardiology IV™	6155	FDA UDI	Class I	Active
Fast Release Varnish	12158S	FDA UDI	Class II	Active
3M™ Cavilon™	3346P	FDA UDI	Class I	Active
Lava™	1334B1-HT	FDA UDI	Class II	Unknown
3M™ Cavilon™	3346NP	FDA UDI	Class I	Active
Ranger™	90030	FDA UDI	Class II	Active
Red Dot™	9642	FDA UDI	Class II	Active
3M™ Medipore™	2863	FDA UDI	Class I	Active
3M™ Littmann® Cardiology IV™	6168	FDA UDI	Class I	Active
3M™ Medipore™	3571	FDA UDI	Class I	Active
3M™ Tegaderm™	3588	FDA UDI	Class I	Active
3M™ Unitek™	907022	FDA UDI	Class I	Active
3M™ Unitek™	902150	FDA UDI	Class I	Active
3M™ Durapore™	1590S-2	FDA UDI	Class I	Active
Steri-Drape™	1079	FDA UDI	Class II	Active
Bair Hugger™	64500	FDA UDI	Class II	Active
3M™ Tegaderm™	90212	FDA UDI	Class I	Active
3M™ Littmann®	6242	FDA UDI	Class I	Active
Steri-Drape™	9087	FDA UDI	Class II	Active
3m™ Espe™	940533	FDA UDI	Class I	Active
3M™ Filtek™	6032A3	FDA UDI	Class II	Active
Bair Hugger™	84203	FDA UDI	Class II	Active
Filtek™	6029DU	FDA UDI	Class II	Active
Paradigm™	3710A3	FDA UDI	Class II	Unknown
3M™ Unitek™	900135	FDA UDI	Class I	Active
Bair Paws™	84203	FDA UDI	Class II	Unknown
Bair Paws™	81203	FDA UDI	Class II	Unknown
Bair Hugger™ Novaplus™	42534	FDA UDI	Class II	Active
Steri-Drape™	9012	FDA UDI	Class II	Active
Nexcare™ Ultra Stretch MAXI Flexible Comfort Bandages	N8-5-1M	EUDAMED	Class I	Active
FUTURO™ Premium Compression Knee Sleeve with Stabilizers	49003SPEA	EUDAMED	Class I	Active
Aseptex 1812 Sub-Micron Molded Surgical Mask	K890771	FDA 510(k)	Class II	Active
Tenzcare Electrode 6862	K893793	FDA 510(k)	Class II	Active
Relyx Rmgip	K022476	FDA 510(k)	Class II	Active
3m Multi-Aller. Ige Fastscreen S9 W1, 6, 9, 10, 11, 12	K900108	FDA 510(k)	Class II	Active
Sarns Delphin Base Adapter With Mini-Battery	K900601	FDA 510(k)	Class II	Active
Triple Layer Fluid-Resistant Molded Face Mask	K910110	FDA 510(k)	Class II	Active
3m Trimatic M Modular System And Accessories	K880565	FDA 510(k)	Class II	Active
Allergen Specific Igg4 Control Sera	K870153	FDA 510(k)	Class II	Active
3M V.A.C. Peel and Place Dressing Kit, Small (EZ10SML), 3M V.A.C. Peel and Place Dressing Kit, Medium (EZ10MED), 3M V.A.C. Peel and Place Dressing Kit, Large (EZ10LRG)	K222859	FDA 510(k)	Class II	Active
Sarns Delphin Centrifugal System W/Direction. Flow	K902404	FDA 510(k)	Class II	Active
Tegaderm Transparent Dressing	K811291	FDA 510(k)	Class I	Active
3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)	K222578	FDA 510(k)	Class II	Active
Cast Brace Components	K791057	FDA 510(k)	Class I	Active
3M Attest Rapid Readout Biological Indicator	K200996	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

3M Deutschland GmbH (Medical) DE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (2)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Apr 22, 2025	Z-2231-2025	—	open, classified	Notice was issued to clarify flow rates related to the inlet fluid temperature.
Apr 10, 2025	Z-2483-2025	—	open, classified	Field action to clarify the flow rates and inlet fluid temperatures, along with location of the outlet temperature for Ranger Blood/Fluid Warming High Flow Sets.