FDA.reportPublic FDA data

Welch Allyn, Inc.

Primary DI
10885380071492
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901027
Catalog number
77792-M-CL
Device description
GS 777 INT D DIAG SYS CARDINAL
Published
2020-06-26
Public version status
Update
Distribution status
Not 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
10885380071492PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088538007149210885380071492

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00732094335392Welch Allyn, Inc.90105875RT2022-10-03
00732094335422Welch Allyn, Inc.90105874RT2021-08-25
00732094335439Welch Allyn, Inc.90105874RE2021-08-25
00732094335446Welch Allyn, Inc.90105873RT2021-09-28
00732094335453Welch Allyn, Inc.90105873RE2020-05-15
00732094338751Welch Allyn, Inc.90105874WX2020-08-26
00732094338768Welch Allyn, Inc.90105874WT2020-08-26
00732094338775Welch Allyn, Inc.90105874WE2020-08-26
00732094335385Welch Allyn, Inc.90105875RX2023-04-26
00732094335408Welch Allyn, Inc.90105875RE2023-04-26
00732094335415Welch Allyn, Inc.90105874RX2023-04-26
00732094209167Welch Allyn, Inc.90105875WT-B2017-12-05
00732094209334Welch Allyn, Inc.90105875MX-B2017-12-05
00732094209372Welch Allyn, Inc.90105875MT-B2017-12-05
00732094209518Welch Allyn, Inc.90105875CT-B2017-12-05
00732094209570Welch Allyn, Inc.90105875CE-B2017-12-05
00732094209679Welch Allyn, Inc.90105874MT-B2017-12-05
00732094209792Welch Allyn, Inc.90105874CX-B2017-12-05
00732094209860Welch Allyn, Inc.90105874CT-B2017-12-05
00732094209921Welch Allyn, Inc.90105874CE-B2017-12-05

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
00732094136722Welch 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