FDA.reportPublic FDA data

Hillrom™

Primary DI
00887761980204
Brand
Hillrom™
Company
Baxter Medical Systems GmbH + Co. KG
Model
4068410
Device description
Trumpf Medical/Medizin iLED 7 Ceiling Quad
Published
2021-07-06
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FQPLamp, operating-room
FSQLight, surgical, instrument
FSYLight, surgical, ceiling mounted
FTDLamp, surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQPLamp, Operating-RoomGeneral, Plastic Surgery2
FSQLight, Surgical, InstrumentGeneral, Plastic Surgery2
FSYLight, Surgical, Ceiling MountedGeneral, Plastic Surgery2
FTDLamp, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887761980204PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887761980204008877619802048877619802040887761980204

GMDN Terms#

Term, Definition table
TermDefinition
Operating room lightA device designed to provide a specialized source of light for illumination of a site of medical intervention. It provides a high intensity, high colour rendering field of light that minimizes shadows and the emission of heat. It typically consists of an individual light head with more than one light source which may include halogen bulbs or light-emitting diodes (LEDs), reflectors, mirrors and a mechanism to adjust the focus. This device is usually mounted to the ceiling or wall of an operating room (OR) and the mount may be included. It can be part of an OR light system comprising more than one light head.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4936715860SURGICAL@HILLROM.COM

Regulatory Flags#

DUNS number
330961223
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887761968479VidiaPort40281552023-01-17
00887761968486VidiaPort40281522023-01-17
00887761968493VidiaPort40281502023-01-17
00887761968509VidiaPort40281402023-01-17
00887761968516VidiaPort40281302023-01-17
00887761979840TRUMPF MEDICAL40281522022-11-29
00887761980105TRUMPF MEDICAL40281402022-11-29
00887761980112TRUMPF MEDICAL40281502022-11-29
00887761980129TRUMPF MEDICAL40281552022-11-29
00887761970007Leg Sections20778652022-12-14
00887761970045Head Sections20778602022-12-14
00887761970052Back Sections20775952022-12-14
00887761970144Pelvis Sections20726292022-12-15
00887761970151Leg Sections20726282022-12-15
00887761970168Leg Sections20726262022-12-15
00887761970175Leg Sections20726252022-12-14
00887761970182Back Sections20726242022-12-14
00887761970199Head Sections20726232022-12-14
00887761970014Leg Sections20778642022-12-14
00887761970069Back Sections20775942022-12-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04251339907300YLED-3F (including Portegra)MAVIG GmbHFSY2026-07-21
04251339907317YLED-3F (including Portegra)MAVIG GmbHFSY2026-07-21
04251339907324YLED-2F (including Portegra)MAVIG GmbHFSY2026-07-21
04251339907348YLED-2F (including Portegra)MAVIG GmbHFSY2026-07-21
04251339907362YLED-2F (including Portegra)MAVIG GmbHFSY2026-07-21
04251339907379YLED-3F (including Portegra)MAVIG GmbHFSY2026-07-21
03700712436124VolistaMAQUET SASFSY2026-07-20
03700712436131VolistaMAQUET SASFSY2026-07-20
03700712436148VolistaMAQUET SASFSY2026-07-20
03700712436155VolistaMAQUET SASFSY2026-07-20
03700712436162VolistaMAQUET SASFSY2026-07-20
03700712436179VolistaMAQUET SASFSY2026-07-20
03700712436186VolistaMAQUET SASFSY2026-07-20
03700712436193VolistaMAQUET SASFSY2026-07-20
03700712436209VolistaMAQUET SASFSY2026-07-20
03700712436216VolistaMAQUET SASFSY2026-07-20
03700712436223VolistaMAQUET SASFSY2026-07-20
03700712436230VolistaMAQUET SASFSY2026-07-20
03700712436247VolistaMAQUET SASFSY2026-07-20
03700712436254VolistaMAQUET SASFSY2026-07-20
03700712436261VolistaMAQUET SASFSY2026-07-20
03700712436278VolistaMAQUET SASFSY2026-07-20
03700712436285VolistaMAQUET SASFSY2026-07-20
03700712436292VolistaMAQUET SASFSY2026-07-20
03700712436308VolistaMAQUET SASFSY2026-07-20
03700712436315VolistaMAQUET SASFSY2026-07-20
03700712436322VolistaMAQUET SASFSY2026-07-20
03700712436339VolistaMAQUET SASFSY2026-07-20
03700712436346VolistaMAQUET SASFSY2026-07-20
03700712436353VolistaMAQUET SASFSY2026-07-20