Identity
- Trade Name
- FlowSense FDA UDI
- Generic Name
- Pulmonary resuscitator, manual, single-use FDA UDI
- Device Name
- FlowSense (ref: A0000047) is the single use sensor used with EOlife (ref: AUS00055). FlowSense is the consumable of EOlife. FlowSense is sold in boxes of 10 units under the sales reference A0000044. FDA UDI
- Model / Reference
- A0000047 FDA UDI
- Description
- FlowSense (ref: A0000047) is the single use sensor used with EOlife (ref: AUS00055). FlowSense is the consumable of EOlife. FlowSense is sold in boxes of 10 units under the sales reference A0000044. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 13770016085011 FDA UDI
- 510(k) Number
- K221841 FDA UDI
- FDA Product Code
- BTM FDA UDI
- GMDN Term
- Pulmonary resuscitator, manual, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5915 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
MR Unsafe FDA UDI
Category: Pulmonary resuscitator, manual, single-use
FlowSense by Archeon — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Pulmonary resuscitator, manual, single-use.
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- SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator — Ambu A/S · Class II
- Ventlab — Ventlab Corp. · Class I
- Ventlab — Ventlab Corp. · Class II
- Ambu® SPUR® II Pediatric Resuscitator — Ambu A/S · Class II
Cleared under the same submission
K221841 also covers:
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 II | Pending data |
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Manufacturer
- Manufacturer
- Archeon
Sources (1)
- FDA UDI 23c2a66d-8ff5-4476-b32c-38bf20a792de 34 fields · synced Jun 1, 2026