FDA.report

Welch Allyn, Inc.

Primary DI
00732094098952
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901006
Catalog number
6200-05
Device description
ECG Lead Wires, 3-Lead
Published
2021-04-22
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
HKMRetinoscope, battery-powered

Product Code Classifications

CodeDeviceSpecialtyClass
HKMRetinoscope, Battery-PoweredOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00732094098952PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00732094098952007320940989527320940989520732094098952

GMDN Terms

TermDefinition
Electrocardiographic lead set, reusableA collection of noninvasive devices intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It includes an insulated metal wire(s) with a detachable or permanently attached electrode, and may include a cable with connector; some types may be designed as a pre-configured array (e.g., EEG belt) to assist electrode placement. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(315)685-2834gdsn_support@MyHillRom.onmicrosoft.com

Regulatory Flags

DUNS number
198227881
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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00732094360363Welch Allyn, Inc.901144QS-6AA-AEAAA2026-02-03
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00732094357929Welch Allyn, Inc.90102671-XM2LXE2025-11-25
00732094358933Welch Allyn, Inc.901203C360KIT95RXTBWLJBP2025-11-24
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00732094358971Welch Allyn, Inc.901203C360KIT95CXTBWLJBP2025-11-24
00732094358988Welch Allyn, Inc.901203C360KIT95CXTBMBJX2025-11-24
00732094237740Welch Allyn, Inc.901049CP150A2025-09-22
00732094356366Welch Allyn, Inc.9010069293-046-572025-09-22
00732094356373Welch Allyn, Inc.9010069293-046-552025-09-22
00732094356380Welch Allyn, Inc.9010069293-046-062025-09-22
00732094356397Welch Allyn, Inc.9010069293-046-052025-09-22
00732094356403Welch Allyn, Inc.9010069293-046-042025-09-22
00732094356410Welch Allyn, Inc.9010069293-046-032025-09-22
00732094309225Welch Allyn, Inc.90105744XT2021-04-26
06932825304237Welch Allyn, Inc.9011232000 PLUS-A2025-08-08

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
04053755202508BETA 200 LED RETINOSCOPEHeine Optotechnik GmbH & Co. KGHKM2024-07-16
00732094087727Welch Allyn, Inc.WELCH ALLYN, INC.HKM2023-08-17
04053755191673BETA 200 LED RETINOSCOPEHeine Optotechnik GmbH & Co. KGHKM2022-12-12
00732094098914Welch Allyn, Inc.WELCH ALLYN, INC.HKM2021-04-22
04045396010819ri-scope® retinoscope head slit XL 3.5 VRudolf Riester GmbHHKM2021-01-28
04045396129931ri-scope® retinoscope head slit XL 3.5 V,Rudolf Riester GmbHHKM2021-01-28
04045396140974ri-vision with retinoscope slit XL 3.5 V, C-handleRudolf Riester GmbHHKM2021-01-28
04045396182646ri-vision with slit retinoscope XL/LED 3,5V, C hanRudolf Riester GmbHHKM2021-01-28
04045396182660ri-vision with slit retinoscope XL/LED 3,5V/120V,Rudolf Riester GmbHHKM2021-01-28
04045396182783ri-vision with slit retinoscope XL/LED 3,5V, C hanRudolf Riester GmbHHKM2021-01-28
00732094087703Welch Allyn, Inc.WELCH ALLYN, INC.HKM2020-01-16
00732094087765Welch Allyn, Inc.WELCH ALLYN, INC.HKM2020-01-16
00732094087772Welch Allyn, Inc.WELCH ALLYN, INC.HKM2020-01-16
00732094087789Welch Allyn, Inc.WELCH ALLYN, INC.HKM2020-01-16
00732094176131Welch Allyn, Inc.WELCH ALLYN, INC.HKM2020-01-16
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06945095531982zumaxZumax Medical Co., LTDHKM2018-08-27
06945095531999zumaxZumax Medical Co., LTDHKM2018-08-27
06945095536000zumaxZumax Medical Co., LTDHKM2018-08-27
06945095531180zumaxZumax Medical Co., LTDHKM2018-07-31
00851158007508Eli EzerU.S. OPHTHALMIC, L.L.C.HKM2018-02-09
00851158007515Eli EzerU.S. OPHTHALMIC, L.L.C.HKM2018-02-09
00732094169584Welch Allyn, Inc.WELCH ALLYN, INC.HKM2018-01-09
00732094146073Welch Allyn, Inc.WELCH ALLYN, INC.HKM2016-09-21
00732094087710Welch Allyn, Inc.WELCH ALLYN, INC.HKM2016-09-17
00732094087734Welch Allyn, Inc.WELCH ALLYN, INC.HKM2016-09-17
00732094087741Welch Allyn, Inc.WELCH ALLYN, INC.HKM2016-09-17