FDA.report

Welch Allyn, Inc.

Primary DI
20817655021137
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901136
Catalog number
716-0237-00
Device description
Assurance Paper, Z-fold pad, red grid, perforated with blank header, 8.5 in. x 11 in. (216mm x 279mm).For use with 8300/8500, Atria, Eclipse Plus/ Premier, and Quest. 200 sheets/pad, Price per case. 10 pads per case.
Published
2020-05-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
DSFRECORDER, PAPER CHART

Product Code Classifications

CodeDeviceSpecialtyClass
DSFRecorder, Paper ChartCardiovascular1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20817655021137PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2081765502113720817655021137

GMDN Terms

TermDefinition
Electrocardiographic recording paperA device prepared from a thin sheet of fibrous material, typically with preprinted graphics and designed for recording the output of an electrocardiograph (ECG), or other device, in the form of measured physiologic parameters as an electrocardiogram (ECG). This is a single-use 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
true
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

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