FDA.reportPublic FDA data

Welch Allyn, Inc.

Primary DI
00732094136722
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901027
Catalog number
77754
Device description
Welch Allyn Green Series 777 Wall Diagnostic System including Coaxial Ophthalmoscope (#11720), 3.5V Halogen HPX Diagnostic Otoscope with Throat Illuminator (#23520); 100-240 V, 50-60 Hz AC, IEC Plug Type-G
Published
2021-05-05
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCWTransformer, EndoscopeGastroenterology, Urology2

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
00732094136722PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00732094136722007320941367227320941367220732094136722

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00732094147629Welch Allyn, Inc.WELCH ALLYN, INC.GCW2023-04-25
00732094144086Welch Allyn, Inc.WELCH ALLYN, INC.GCW2023-04-25
00732094136715Welch Allyn, Inc.WELCH ALLYN, INC.GCW2021-05-05
00732094136760Welch Allyn, Inc.WELCH ALLYN, INC.GCW2021-05-05
00732094174021Welch Allyn, Inc.WELCH ALLYN, INC.GCW2021-05-05
00304040090664Henry ScheinHENRY SCHEIN, INC.GCW2021-04-23
00732094342055Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094342079Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094342130Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094342154Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094342031Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094342048Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094342062Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094342086Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094342093Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094342109Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094342116Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094342123Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094342147Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094342161Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094342178Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094342185Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094341805Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-10
00732094341812Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-10