FDA.reportPublic FDA data

Welch Allyn, Inc.

Primary DI
00732094337297
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901027
Catalog number
777-SM2WAX
Device description
GS777 IntWallSys 117 MV w BP
Published
2020-07-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCWTransformer, endoscope
HLIOphthalmoscope, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCWTransformer, EndoscopeGastroenterology, Urology2
HLIOphthalmoscope, Ac-PoweredOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K771864000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K771864000WALL TRANSFORMERS 74710 & 74910Welch Allyn, Inc.1977-11-22GCW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00732094337297PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00732094337297007320943372977320943372970732094337297

GMDN Terms#

Term, Definition table
TermDefinition
Aneroid manual sphygmomanometerA device designed to measure blood pressure consisting of an inflatable cuff that fits around a limb (arm or thigh), an inflation bulb for controlling the air pressure within the cuff, an aneroid manometer, and tubing. The aneroid manometer consists of a metal bellows, which expands as the pressure in the cuff increases, and a mechanical amplifier that transmits this expansion through a lever to an indicator needle, which rotates around a circular, calibrated scale. The manometer may be mounted to a wall, placed on a table, or hand held (portable); blood pressure measurement is taken in conjunction with a stethoscope.

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
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00732094356366Welch Allyn, Inc.9010069293-046-572025-09-22
00732094356373Welch Allyn, Inc.9010069293-046-552025-09-22
00732094319903Welch Allyn, Inc.9010114198322023-09-26
00732094326079Welch Allyn, Inc.9010069293-024-512023-08-25
00732094247138Welch Allyn, Inc.90103139500-TE2019-08-28
00732094247145Welch Allyn, Inc.90103139500-NP-TE2019-08-28
00732094272338Welch Allyn, Inc.90115211094-001-502020-03-24
00732094258905Welch Allyn, Inc.90113411012-014-502020-03-20
00732094307351Welch Allyn, Inc.9011454197512019-10-23
00732094307368Welch Allyn, Inc.9011454133792019-10-23
00732094307375Welch Allyn, Inc.9011454197332019-10-23
00732094258998Welch Allyn, Inc.901011036840-0052019-09-26
00732094272673Welch Allyn, Inc.901011036840-0062019-09-26
00817655020679Welch Allyn, Inc.90113411012-016-502019-09-26
00817655020686Welch Allyn, Inc.90113411012-016-512019-09-26
00732094296341Welch Allyn, Inc.90101211093-003-502019-06-11
00732094223910Welch Allyn, Inc.9011084112152023-08-24
00732094089226Welch Allyn, Inc.901020118402016-09-17
00732094089240Welch Allyn, Inc.901022118202016-09-17
00732094183948Welch Allyn, Inc.90102211820-L2016-09-17

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06945095544500zumaxZumax Medical Co., LTDHLI2026-05-20
06942576062461RobotrakRobotrak Technologies Co., LtdHLI2026-04-30
00697077003081Amico Diagnostic StationAmico Diagnostic IncorporatedHLI2025-07-14
04549292147216CANON INC.CANON INC.HLI2025-05-02
00697077003050Amico Diagnostic, Inc.Amico Diagnostic IncorporatedHLI2024-09-18
00697077003043Amico Diagnostic WallboardAmico Diagnostic IncorporatedHLI2024-07-11
00697077003029Amico Diagnostic StationAmico Diagnostic IncorporatedHLI2024-05-02
00732094086515Welch Allyn, Inc.WELCH ALLYN, INC.HLI2023-08-17
00732094087727Welch Allyn, Inc.WELCH ALLYN, INC.HLI2023-08-17
00732094089202Welch Allyn, Inc.WELCH ALLYN, INC.HLI2023-08-17
00732094072709Welch Allyn, Inc.WELCH ALLYN, INC.GCW2023-08-16
00732094073362Welch Allyn, Inc.WELCH ALLYN, INC.GCW2023-08-16
00732094073621Welch Allyn, Inc.WELCH ALLYN, INC.GCW2023-08-16
00732094073683Welch Allyn, Inc.WELCH ALLYN, INC.GCW2023-08-16
00732094073898Welch Allyn, Inc.WELCH ALLYN, INC.GCW2023-08-16
00732094074109Welch Allyn, Inc.WELCH ALLYN, INC.GCW2023-08-16
00697077002237Amico Diagnostic WallboardAmico Diagnostic IncorporatedHLI2023-07-27
00732094147629Welch Allyn, Inc.WELCH ALLYN, INC.GCW2023-04-25
00732094144086Welch Allyn, Inc.WELCH ALLYN, INC.GCW2023-04-25
04053755119660INDIRECT OPHTHALMOSCOPE BINOCULARHeine Optotechnik GmbH & Co. KGHLI2022-12-15
04053755120307INDIRECT OPHTHALMOSCOPE MONOCULARHeine Optotechnik GmbH & Co. KGHLI2022-12-15
04053755153541OMEGA 500Heine Optotechnik GmbH & Co. KGHLI2022-12-12
04053755153695OMEGA 500 LEDHeine Optotechnik GmbH & Co. KGHLI2022-12-12
04053755181704OMEGA 500Heine Optotechnik GmbH & Co. KGHLI2022-12-12
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00732094346954Welch Allyn, Inc.WELCH ALLYN, INC.HLI2022-08-08