FDA.report

NA

Primary DI
00884838010703
Brand
NA
Company
Philips Medizin Systeme Böblingen GmbH
Model
989803104521
Catalog number
989803104521
Published
2016-11-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
IKDCABLE, ELECTRODE

Product Code Classifications

CodeDeviceSpecialtyClass
IKDCable, ElectrodePhysical Medicine2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00884838010703PrimaryGS10

Alternate GTIN/UPC/EAN values are derived from GS1 digit structure for lookup convenience. Do not treat derived UPC-A or EAN-13 values as separate FDA identifiers. GTIN-14 values with indicator digits 1-9 usually represent packaging levels, cases, pallets, or variable-measure items and are not converted to UPC-A/EAN-13 here.

Alternate GTIN / UPC / EAN Codes

Source identifierSource lengthGTIN-14 normalizedIndicatorUPC-AEAN-13Conversion note
00884838010703140088483801070308848380107030884838010703Indicator 0 and prefix 00 allow UPC-A and EAN-13 conversion.

GMDN Terms

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

Contacts

PhoneEmail
+1(999)999-9999xx@xx.xx

Regulatory Flags

DUNS number
314101143
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 DIBrandModelCatalogPublished
00884838117433NOUNDigiTrak XT Patient Cable Short9898031574812026-03-19
00884838113770MR Patient Care Adult SpO2 ClipAdult SpO2 Clip9898031665312026-03-16
00884838100978MR Patient Care Pediatric SpO2 ClipPediatric SpO2 Clip9898031665412026-03-16
00884838128880Patient Information Center iX4.68663892026-03-09
00884838129214Care Assist4.69898032215412026-03-09
00884838129221Care Assist4.69898032215312026-03-09
00884838117877MR Patient Care Pediatric SpO2 ClipPediatric SpO2 Clip9898031665412025-05-22
00884838117358patient lead wireStandard 10-lead Patient Cable IEC9898031849212026-03-05
00884838117273patient lead wireTC ADDITIONAL LEADS KIT: AAMI9898031517512026-03-04
00884838117280patient lead wireTC ADDITIONAL LEADS KIT: IEC9898031517612026-03-04
00884838117297patient lead wireTC ADDITIONAL LONG LEADS KIT: AAMI9898031517712026-03-04
00884838117303patient lead wireTC ADDITIONAL LONG LEADS KIT: IEC9898031517812026-03-04
00884838117310patient lead wirePW TC20 10-Lead Patient Cable IEC9898031758912026-03-04
00884838117327patient lead wirePW TC20 10-Lead Patient Cable AHA9898031759012026-03-04
00884838117334patient lead wirePW TC20 Long 10-Lead Patient Cable IEC9898031759112026-03-04
00884838117341patient lead wirePW TC20 Long 10-Lead Patient Cable AHA9898031759212026-03-04
00884838117198patient lead wirePW CBL Complete Lead Set AAMI9898031516312026-01-16
00884838117204patient lead wirePW CBL Complete Lead Set IEC9898031516412026-01-16
00884838117211patient lead wireLong Complete Lead Set AAMI9898031516512026-01-16
00884838117228patient lead wirePW CBL Long Complete Lead Set IEC9898031516612026-01-16

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20885380208536CARDINAL HEALTHCardinal Health 200, LLCIKD2026-03-03
20885380208543CARDINAL HEALTHCardinal Health 200, LLCIKD2026-03-03
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06941691982920Orantech Orantech Inc.IKD2026-01-16