Identity
- Trade Name
- Paper FDA UDI
- Generic Name
- Electrocardiographic recording paper FDA UDI
- Device Name
- 8.5"x11" Z-fold paper, no header Cardiograph thermal paper. Red Grid. 8.5x11" (216 mm x 279 mm). Pkg = 1 case = 8 packs = 1600 sheets Wgt= 18lbs 5 oz (8.31kg) FDA UDI
- Model / Reference
- Chemical/Thermal Paper FDA UDI
- Description
- 8.5"x11" Z-fold paper, no header Cardiograph thermal paper. Red Grid. 8.5x11" (216 mm x 279 mm). Pkg = 1 case = 8 packs = 1600 sheets Wgt= 18lbs 5 oz (8.31kg) FDA UDI
Identifiers
- Catalog Number
- M1708A FDA UDI
- Primary DI / UDI-DI
- 10884838008387 FDA UDI
- FDA Product Code
- DSF FDA UDI
- GMDN Term
- Electrocardiographic recording paper FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 870.2810 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electrocardiographic recording paper
Paper by Philips Medical Systems Hsg — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Philips Medical Systems Hsg
Sources (1)
- FDA UDI 62bef399-8494-4658-9728-d29edcddd8f4 35 fields · synced May 30, 2026