FDA UDI In Commercial Distribution 🇺🇸 United States

Schiller ECG EL-LT C 1.3/0.78 x4 IEC

DI: 07613365003802 · Model: 2.410099 · Schiller AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Schiller ECG EL-LT C 1.3/0.78 x4 IEC
Primary DI
07613365003802
Version / Model
2.410099
Company Name
Schiller AG
Labeler DUNS
480868538
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-10-09
Public Version
1
Public Version Date
2023-10-17
Public Version Status
New
Public Device Record Key
a4b1e4ab-92f5-4789-bd71-3604343b7944

Device Description

Detachable single wires clip type, Balanced Set 4 pcs (C3r, C4r, C8, C9) for patient cable 2.400140, 2.400139

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
MR Unsafe
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
DSA Cable, Transducer And Electrode, Patient, (Including Connector)

GMDN Terms

Code Name
35562 Electrocardiographic lead set, reusable

Identifiers

Type ID
Primary 07613365003802

Customer Contacts

Phone
+41417664242

Premarket Submissions

Submission Number Supplement Number
K183425 000