FDA.reportPublic FDA data

Welch Allyn, Inc.

Primary DI
00732094098914
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901006
Catalog number
6200-07
Device description
ECG lead wires (3 lead IEC) European Colour coded
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HKMRetinoscope, battery-powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HKMRetinoscope, Battery-PoweredOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00732094098914PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00732094098914007320940989147320940989140732094098914

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00732094055245Welch Allyn, Inc.901001SM25512026-03-06
00887761976283Life2000MS-01-01252026-02-09
00887761978041Life2000MS-01-01212026-02-09
00732094360363Welch Allyn, Inc.901144QS-6AA-AEAAA2026-02-03
00732094360370Welch Allyn, Inc.901144XSCRIBE-6AA-ACAAA2026-02-03
00732094360295Welch Allyn, Inc.901204 v7.4.2E100012025-12-18
00732094357929Welch Allyn, Inc.90102671-XM2LXE2025-11-25
00732094358933Welch Allyn, Inc.901203C360KIT95RXTBWLJBP2025-11-24
00732094358957Welch Allyn, Inc.901203C360KIT95MXTBWLJBP2025-11-24
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 DI, Brand, Company table
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
00732094098952Welch 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
06945095531005zumaxZumax Medical Co., LTDHKM2018-08-27
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