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ANNE Limb Adhesive Shelf Box
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 900-00071Model SA-004-01
Identity
- Trade Name
- ANNE Limb Adhesive EUDAMEDANNE Limb Adhesive Shelf Box FDA UDI
- Generic Name
- Pulse oximeter FDA UDI
- Device Name
- ANNE One System EUDAMEDBox of 50 ANNE Limb Adhesives FDA UDI
- Model / Reference
- SA-004-01 EUDAMED900-00071 EUDAMED900-00011 FDA UDI
- Description
- Box of 50 ANNE Limb Adhesives FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850064210293 EUDAMED00850064210125 FDA UDI
- Basic UDI-DI
- 08500642100JG EUDAMED
- 510(k) Number
- K240305 FDA UDI
- FDA Product Code
- DQA FDA UDIDRG FDA UDIFLL FDA UDI
- EMDN Code
- Z1203020285 MULTI-PARAMETER MONITORS - CONSUMABLES EUDAMED
- GMDN Term
- Pulse oximeter FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2700 FDA UDI870.2910 FDA UDI880.2910 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Pulse oximeter
ANNE Limb Adhesive Shelf Box by Sibel Health Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Pulse oximeter.
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Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Sibel Health Inc.
Sources (2)
- FDA UDI ab74f10e-7550-4dc5-b61a-47727022ed64 34 fields · synced Jul 10, 2026
- EUDAMED 8303f8ab-3526-42e6-9cec-bc92a764acc4 61 fields · synced Jul 10, 2026