Identity
- Trade Name
- OTS - Active Shooter FDA UDI
- Generic Name
- Non-rebreathing valve, single-use FDA UDI
- Device Name
- OTS - Active Shooter FDA UDI
- Model / Reference
- K617-029 FDA UDI
- Description
- OTS - Active Shooter FDA UDI
Identifiers
- Catalog Number
- K617-029 FDA UDI
- Primary DI / UDI-DI
- 00766588170299 FDA UDI
- FDA Product Code
- EFQ FDA UDILRR FDA UDICBP FDA UDI
- GMDN Term
- Non-rebreathing valve, single-use FDA UDI
Classification
- Device Class
- U FDA UDI
- Regulation Number
- 868.5870 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: First aid kit, medicatedNon-woven gauze padWound-nonadherent dressing, absorbent, non-antimicrobialNon-rebreathing valve, single-use
OTS - Active Shooter by Certified Safety Manufacturing, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Non-rebreathing valve, single-use.
- Medline/MMS Sales — MEDLINE INDUSTRIES, INC. · Class I
- Medline/MMS Sales — MEDLINE INDUSTRIES, INC. · Class I
- Curaplex — BOUND TREE MEDICAL, LLC · Class I
- Medline/MMS Sales — MEDLINE INDUSTRIES, INC. · Class I
- HUDSON RCI — TELEFLEX INCORPORATED · Class I
- Teleflex/Hudson RCI — MEDLINE INDUSTRIES, INC. · Class II
- Medline/MMS Sales — MEDLINE INDUSTRIES, INC. · Class I
- Teleflex/Hudson RCI — MEDLINE INDUSTRIES, INC. · Class II
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 U | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Certified Safety Manufacturing, Inc.
Sources (1)
- FDA UDI 54e75538-e353-4f5a-acc9-37d6e6cf5c91 35 fields · synced May 31, 2026