FDA.report

MEDLINE

Primary DI
10193489136241
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
MDSLS4SETL
Catalog number
MDSLS4SETL
Device description
OTO/OPH POCKET SET,2.5V LED,W/CASE
Published
2024-11-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HLJOphthalmoscope, battery-powered

Product Code Classifications

CodeDeviceSpecialtyClass
HLJOphthalmoscope, Battery-PoweredOphthalmic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10193489136241PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1019348913624110193489136241

GMDN Terms

TermDefinition
Ophthalmic/otologic diagnostic setA collection of battery-powered devices intended to be used by a physician to perform an ophthalmic and/or otoscopic clinical examination on a patient. The devices are typically enclosed in a dedicated case and will typically include an ophthalmoscope and an otoscope, a dedicated interchangeable handle that contains the batteries which may be rechargeable and common to these examination devices, spare parts (e.g., extra ear specula, light bulbs) may include a line-powered charging station (e.g., desktop, wall-mounted) to house/charge these devices. This is a reusable device that may contain some disposable devices.

Storage And Handling

TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Special Storage Condition, Specify00Keep Dry. Keep away from sunlight.
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags

DUNS number
025460908
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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10884389110010MEDLINECRI5000BCRI5000B2026-03-24
10884389110072MEDLINENONTH200BNONTH200B2026-03-24
30193489036224MEDLINEMDSE2RDCAMDSE2RDCA2022-12-10
30193489036248MEDLINEMDSE2RDCPMDSE2RDCP2022-12-10
30193489036262MEDLINEMDSE2X2CAMDSE2X2CA2022-12-10
40888277170897MEDLINEFG1501FG15012026-03-20
40888277170972MEDLINEFG1503FG15032026-03-20
40888277358455MEDLINEMPHPN315MPHPN3152026-03-19
40888277358462MEDLINEMPHPN318MPHPN3182026-03-19
20197344009807HUDSON RCIHUD2417HUD24172026-03-19
20080196286789MEDLINEMDT2168282MDT21682822016-10-14
20080196765574MEDLINE INDUSTRIES, INC.NONLV200NONLV2002025-05-28
10197344010264HUDSON RCIHUD1846HUD18462026-03-19
20884389108199MEDLINE INDUSTRIES, INC.NONLV200XXXLNONLV200XXXL2024-03-05
20884389108229MEDLINENONLV200XXLNONLV200XXL2025-05-27
20884389155360MEDLINENONLV240NONLV2402025-05-27
20884389155377MEDLINENONLV240XLNONLV240XL2025-05-27
20888277336893MEDLINENON50240NON502402025-05-27

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
16972545090024JeashiaZhejiang Honsun Medical Technology Co., Ltd.HLJ2026-02-03
06972545090133JeashiaZhejiang Honsun Medical Technology Co., Ltd.HLJ2026-02-02
00732094357929Welch Allyn, Inc.WELCH ALLYN, INC.HLJ2025-11-25
04053755202966BETA X OPHTHALMOSCOPEHeine Optotechnik GmbH & Co. KGHLJ2025-07-17
00732094357936Welch Allyn, Inc.WELCH ALLYN, INC.HLJ2025-03-27
00732094357943Welch Allyn, Inc.WELCH ALLYN, INC.HLJ2025-03-27
10193489136210MEDLINEMEDLINE INDUSTRIES, INC.HLJ2024-09-09
00810149097515R&D Batteries, Inc.R & D Batteries, Inc.HLJ2024-08-28
04053755202232K 180 LED OPHTHALMOSCOPEHeine Optotechnik GmbH & Co. KGHLJ2024-06-27
00850038195335Eli EzerU.S. OPHTHALMIC, L.L.C.HLJ2024-04-03
00850038195342Eli EzerU.S. OPHTHALMIC, L.L.C.HLJ2024-04-03
00810149090684R&D Batteries, Inc.R & D Batteries, Inc.HLJ2024-01-01
00810149090745R&D Batteries, Inc.R & D Batteries, Inc.HLJ2024-01-01
00810149090837R&D Batteries, Inc.R & D Batteries, Inc.HLJ2024-01-01
00810149091056R&D Batteries, Inc.R & D Batteries, Inc.HLJ2024-01-01
00810149091148R&D Batteries, Inc.R & D Batteries, Inc.HLJ2024-01-01
00810149092039R&D Batteries, Inc.R & D Batteries, Inc.HLJ2024-01-01
00810149093630R&D Batteries, Inc.R & D Batteries, Inc.HLJ2024-01-01
00810149093647R&D Batteries, Inc.R & D Batteries, Inc.HLJ2024-01-01
00810149094637R&D Batteries, Inc.R & D Batteries, Inc.HLJ2024-01-01
00810149094644R&D Batteries, Inc.R & D Batteries, Inc.HLJ2024-01-01
00634782601669Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2023-12-15
04030155000392EUROLIGHT E30, 2.5V ophthalmoscope with clic-closureKirchner & Wilhelm GmbH + Co KGHLJ2023-09-04
04030155001542BASIC-SET COMBILIGHT C10/E10 ophthalmoscope and otoscopeKirchner & Wilhelm GmbH + Co KGHLJ2023-09-04
04053755120000BETA 200 S OPHTHALMOSCOPEHeine Optotechnik GmbH & Co. KGHLJ2022-12-15
04053755120017K 180 OPHTHALMOSCOPEHeine Optotechnik GmbH & Co. KGHLJ2022-12-15
04053755119981BETA 200 OPHTHALMOSCOPEHeine Optotechnik GmbH & Co. KGHLJ2022-12-12
00733657274714ADSTATION OTO LED/OPH COAX LED W/SPECALIMED, INC.HLJ2022-12-01
00732094347074Welch Allyn, Inc.WELCH ALLYN, INC.HLJ2022-08-05
00732094347081Welch Allyn, Inc.WELCH ALLYN, INC.HLJ2022-08-05