Identity
- Trade Name
- AMSafe® 84" (213cm) 10 Drop Gravity Set FDA UDI
- Generic Name
- Basic intravenous administration set, noninvasive FDA UDI
- Device Name
- AMSafe® 84" (213cm) 10 Drop Gravity Set w/Pre-Slit Port, MicroClave® Clear, Rotating Luer, Drop-In Pressure Infusion (400 psig) Ext Set w/MicroClave® Clear, Slide Clamp, Rotating Luer, Approx Priming Volume: 11.0mL FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- AMSafe® 84" (213cm) 10 Drop Gravity Set w/Pre-Slit Port, MicroClave® Clear, Rotating Luer, Drop-In Pressure Infusion (400 psig) Ext Set w/MicroClave® Clear, Slide Clamp, Rotating Luer, Approx Priming Volume: 11.0mL FDA UDI
Identifiers
- Catalog Number
- MRS10P-84 FDA UDI
- Primary DI / UDI-DI
- 10704411004639 FDA UDI
- 510(k) Number
- K964435 FDA UDI
- FDA Product Code
- FMG FDA UDI
- GMDN Term
- Basic intravenous administration set, noninvasive FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5440 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Category: Basic intravenous administration set, noninvasive
AMSafe® 84" (213cm) 10 Drop Gravity Set by Amsino International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K964435 also covers:
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- ICU Medical — ICU MEDICAL, INC.
- ICU Medical — ICU MEDICAL, INC.
- ICU Medical — ICU MEDICAL, INC.
- ICU Medical — ICU MEDICAL, INC.
- ICU Medical — ICU MEDICAL, INC.
- ICU Medical — ICU MEDICAL, INC.
- ICU Medical — ICU MEDICAL, INC.
- ICU Medical — ICU MEDICAL, INC.
- ICU Medical — ICU MEDICAL, INC.
- ICU Medical — ICU MEDICAL, INC.
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
- Amsino International, Inc.
Sources (1)
- FDA UDI 26146cfd-e8cc-4cf6-ab4f-9e9274c598a9 35 fields · synced Jun 1, 2026