Identity
- Trade Name
- Medline FDA UDI
- Generic Name
- Progastrin-releasing peptide (ProGRP) IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- FILTER,PULM,FUNCTION,ROUND,REG,BLUE FDA UDI
- Model / Reference
- DYNJ757NB FDA UDI
- Description
- FILTER,PULM,FUNCTION,ROUND,REG,BLUE FDA UDI
Identifiers
- Catalog Number
- DYNJ757NB FDA UDI
- Primary DI / UDI-DI
- 10888277652361 FDA UDI
- 510(k) Number
- K042758 FDA UDI
- FDA Product Code
- BZG FDA UDI
- GMDN Term
- Progastrin-releasing peptide (ProGRP) IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1840 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Progastrin-releasing peptide (ProGRP) IVD, kit, fluorescent immunoassay
Medline by Medline Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Progastrin-releasing peptide (ProGRP) IVD, kit, fluorescent immunoassay.
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
Cleared under the same submission
K042758 also covers:
- MCG Diagnostics — MEDICAL GRAPHICS CORP.
- MGC Diagnostics — MEDICAL GRAPHICS CORP.
- MGC Diagnostics — MEDICAL GRAPHICS CORP.
- MGC Diagnostics — MEDICAL GRAPHICS CORP.
- MGC Diagnostics — MEDICAL GRAPHICS CORP.
- MGC Diagnostics — MEDICAL GRAPHICS CORP.
- MGC Diagnostics — MEDICAL GRAPHICS CORP.
- MGC Diagnostics — MEDICAL GRAPHICS CORP.
- MGC Diagnostics — MEDICAL GRAPHICS CORP.
- MGC Diagnostics — MEDICAL GRAPHICS CORP.
- MGC Diagnostics — MEDICAL GRAPHICS CORP.
- MGC Diagnostics — MEDICAL GRAPHICS CORP.
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
- Medline Industries, Inc.
Sources (1)
- FDA UDI 8193b97c-edb6-4e6b-bc5a-80f351203c4b 36 fields · synced Jun 1, 2026