Identity
- Trade Name
- Aero-Med FDA UDI
- Generic Name
- General specimen collection kit FDA UDI
- Device Name
- Bone Marrow Lab Kit, St. Luke's University Health Network, Bethlehem PA Only FDA UDI
- Model / Reference
- CA23450 FDA UDI
- Description
- Bone Marrow Lab Kit, St. Luke's University Health Network, Bethlehem PA Only FDA UDI
Identifiers
- Catalog Number
- CA23450 FDA UDI
- Primary DI / UDI-DI
- 10885380175237 FDA UDI
- FDA Product Code
- OIB FDA UDI
- GMDN Term
- General specimen collection kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.3250 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
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: General specimen collection kit
Aero-Med by Aero-Med Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General specimen collection kit.
- TUD NA CITRATE 0.109M 3ML — TUD SDN BHD · Class A
- GN Broth — Copan Italia S.P.A. · Class A
- Centurion — Centurion Medical Products · Class I
- MEDLINE — MEDLINE INDUSTRIES, INC. · Class I
- LBM LIM Broth — Copan Italia S.P.A. · Class A
- BBL™ CultureSwab™ Plus — COPAN ITALIA SPA · Class I
- Transystem™ — COPAN ITALIA SPA · Class I
- UTM® — COPAN ITALIA SPA · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Aero-Med Llc
Sources (1)
- FDA UDI db1e5c6d-8f75-4b4c-aeb4-6e6e402757c8 35 fields · synced May 31, 2026